FDA Approves Ogsiveo for Adults with Desmoid Tumors
SpringWorks Therapeutics, Inc., announced today that the U.S. Food and Drug Administration has approved Ogsiveo™ (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track, and orphan drug designations to nirogacestat for the treatment of desmoid tumors.
Desmoid tumors are locally aggressive and invasive soft-tissue tumors that can lead to substantial morbidity. In addition, when vital structures are impacted, desmoid tumors can be life threatening. Although they do not metastasize, desmoid tumors are often refractory to existing off-label systemic therapies and associated with recurrence rates of up to 77% following surgical resection. Desmoid tumor experts and treatment guidelines now recommend systemic therapies as first-line intervention instead of surgery for most tumor locations requiring treatment.
Ogsiveo (nirogacestat) is not approved for the treatment of any other indication in the United States, or for any indication in any other jurisdiction by any other health authority.
SpringWorks is also evaluating nirogacestat as a potential treatment for patients with ovarian granulosa cell tumors and for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with leaders in industry and academia.
SpringWorks expects to file a Marketing Authorization Application for Ogsiveo in desmoid tumors with the European Medicines Agency in the first half of 2024.
Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte Capsules, Artri King, Capsules, and Reumo Flex Capsules to the consumer level. FDA analysis has found the Kuka Flex Forte Capsules, Artri King Capsules, and Reumo Flex Capsules, to be tainted with Diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), however, the presence of Diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses. To date, Botanical-Be has not received any reports of adverse events related to this recall.
These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and are packaged as followed:
Artri King distributed in the bottles with 100 capsules.
Kuka Flex distributed in the bottles with 30 capsules.
Reumo Flex distributed in the boxes with 30 capsules.
The affected product lots include the following lot numbers and expirations: Artri King lot 35421, with an expiration date of December 19, 2025; Kuka Flex Forte; all lots with an expiration date of December 12, 2024, and UPC code 0736640810265; Reumo Flex; all lots with an expiration date of October 20, 2024.
These products were distributed nationwide via the internet. Botanical-Be is notifying its customers via email and is arranging for the return of all recalled products.
Consumers in possession of these products should cease usage immediately and return them to the place of purchase.
For any queries related to this recall, consumers can contact Botanical-Be by phone at (915) 412-6237 or by e-mail at botanical.be@gmail.com on Monday to Friday from 8:00 am to 5:pm, Mountain standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
(BeneCard does not carry the noted manufactured drugs)
FDA Approves Maxigesic® IV to be Marketed in the U.S. as Combogesic® IV (acetaminophen and ibuprofen) for the Management of Pain
October 18, 2023 – Hyloris Pharmaceuticals SA), today announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.
The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
Distribution of Combogesic® IV in U.S. hospitals should start in early 2024.
Medically reviewed by Carmen Pope, BPharm. By Elana Gotkine HealthDay Reporte
For patients undergoing open lumbar laminectomy, ultrasound-guided bilateral erector spinae plane blocks (ESPBs) combined with multimodal analgesia reduce opioid consumption, according to a study recently published in the European Spine Journal.
Jesse W. Stewart, M.D., from UT Southwestern Medical Center in Dallas, and colleagues compared the analgesic effects of preoperative, bilateral, ultrasound-guided ESPBs combined with standardized multimodal analgesia with multimodal analgesia alone (25 patients in each group) among patients undergoing one or two level open lumbar laminectomy.
The researchers found that with ESPBs, opioid requirements at 24 hours were significantly lower (31.9 ± 12.3 versus 61.2 ± 29.9 mg oral opioid equivalents). In the post-anesthesia care unit (PACU) and through postoperative day two, pain scores were significantly lower with ESPBs. Fewer patients in the ESPB group versus the non-ESPB group received postoperative antiemetic therapy (12 versus 48 percent). In addition, significantly shorter PACU duration was seen with ESPBs (49.7 ± 9.5 versus 79.9 ± 24.6 minutes).
“These findings suggest that ESPBs can play a major role in an opioid-sparing recovery plan that utilizes a multimodal pain management approach, not only in spine surgery but potentially for other types of surgery as well,” Stewart said in a statement
Earlier onset of atrial fibrillation (AF) is associated with increased risk of developing all-cause dementia, vascular dementia (VD), and Alzheimer disease (AD), according to a study published online Nov. 8 in JAMA Network Open.
Wenya Zhang, from the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing, and colleagues conducted a population-based cohort study using data from the U.K. Biobank to examine whether age at AF diagnosis is associated with risk of incident dementia and its subtypes. The main analysis included 433,746 participants.
The researchers found that compared to individuals without AF, the 30,601 with AF had increased risk of developing all-cause dementia and VD (adjusted hazard ratios, 1.42 and 2.06, respectively), but not AD. Younger age at AF onset was associated with increased risks of developing all-cause dementia, AD, and VD (adjusted hazard ratio per 10-year decrease, 1.23, 1.27, and 1.35, respectively). For developing all cause dementia, the highest hazard ratio was seen for individuals with AF diagnosed before age 65 years, followed by AF diagnosed at age 65 to 74 years (adjusted hazard ratios, 1.82 and 1.47, respectively) after propensity-score matching; the hazard ratio for AF diagnosed at ≥75 years was not significant. Results were similar for AD and VD.
“The quantitative manifestation of the association between AF onset age and incident dementia highlights the importance of monitoring cognitive function among AF patients, especially those younger than 65 years at diagnosis,” the authors write.
The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.
The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use in individuals 6 months through 11 years of age.
Summary of the Issue
FDA has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine. Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual. However, the volume of a single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is only 0.25mL.
Information for Healthcare Providers
We are advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient. To provide clarification, the Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.
Healthcare providers, parents and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.
FDA Approves Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
Catalyst Pharmaceuticals, Inc. has reported that Santhera Pharmaceuticals has obtained U.S. Food and Drug Administration (“FDA”) approval for Agamree® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older.
Agamree offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need.
Agamree was granted Orphan Drug and Rare Pediatric Disease designations status for DMD in the U.S. and will be eligible for seven years of orphan drug exclusivity upon approval date and has issued pending patents that could provide protection until 2040.
In July 2023, Catalyst secured the exclusive North American license and commercial rights for Agamree from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for Agamree to Catalyst. The company plans to launch the product in Q1 2024.
Agamree’s unique mode of action is based on differential effects on glucocorticoid and mineralocorticoid receptors and modifying further downstream activity and, as such, is considered a novel corticosteroid with dissociative properties in maintaining efficacy, with a better-tolerated side effect profile. This mechanism of action may allow vamorolone to emerge as an effective alternative to the current standard of care corticosteroids in children, adolescents, and adult patients with DMD.
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.
Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.
8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754- 5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2).
The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
Product was distributed nationwide to wholesalers, distributors, and health systems between January 18, 2022, and February 15, 2023.
Midazolam in 0.8% Sodium Chloride Injection is used for sedation and is packaged in a 100 mL glass vial, 25 vials per corrugated shipper. The vials are labeled with Exela brand (Carton NDC: 51754-2131- 4; Vial NDC: 51754-2131-1, Figure 3).
The affected Midazolam in 0.8% Sodium Chloride Injection 100 mg/ 100 mL include the following lot number and expiration date:
Product was distributed nationwide to wholesalers, distributors, and health systems between July 14, 2023, and September 26, 2023.
ELCYS (cysteine hydrochloride Injection) is used for nutritional requirements per total parenteral nutrition (TPN) and is packaged in a 10 mL glass vial, 10 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-1007-3; Vial NDC: 51754-1007-1, Figure 4).
The affected ELCYS (cysteine hydrochloride Injection), USP 50 mg/mL includes the following lot number and expiration date:
The product was distributed nationwide to wholesalers, distributors, health systems, and compounders between July 20, 2023, and August 1, 2023.
Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product, which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela. Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email at recall@exela.us Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
(No BeneCard members were affected by this drug recall.)
FDA Reporting Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. • Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.
Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.
8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2). The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
Product was distributed nationwide to wholesalers, distributors, and health systems between January 18, 2022, and February 15, 2023.
FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents
Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause most invasive meningococcal disease (IMD) globally.
Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities. Penbraya reduces the total number of doses needed for individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the standard of care, and potentially increasing the number of adolescents and young adults vaccinated.
According to the U.S. Centers for Disease Control and Prevention (CDC), combining vaccines into fewer shots may mean that more adolescents and young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases. Routine use of Penbraya could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection (sequelae) in survivors and costs associated with controlling outbreaks.
