Monthly Archives: October 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Teclistamab-cqyv was evaluated in MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi- cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.

AstraZeneca’s Imjudo (tremelimumab), in combination with Imfinzi (durvalumab), has been approved by the FDA for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the combination, which includes a single dose of the anti-CTLA-4 antibody Imjudo 300mg added to the anti- PD-L1 antibody Imfinzi 1500mg followed by Imfinzi every four weeks is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the HIMALAYA Phase III trial. In this trial, patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death versus sorafenib. Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib still alive at the same duration of follow-up.

AbbVie (NYSE: ABBV) today announces that the U.S. Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. This additional indication follows the FDA approval of Rinvoq in April of this year for adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers, making it the first and only JAK inhibitor that is approved for both conditions. Originally approval by the FDA on August 16, 2019, Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

• Read more… Rinvoq (upadacitinib) Receives FDA Approval for the Treatment of Adults with Active NonRadiographic Axial Spondyloarthritis

The U.S. Food and Drug Administration (FDA) approved an expansion of the indication for Eli Lilly and Company’s rapid-acting mealtime insulin Lyumjev® (insulin lispro-aabc) injection to include the improvement of glycemic control in children with diabetes. Lyumjev can be administered subcutaneously either at the start of a meal or within 20 minutes after starting a meal, or as a continuous subcutaneous insulin infusion (CSII) with an insulin pump. Originally approval by the FDA on June 15, 2020, Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

• Read more… Lyumjev (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes

The US Food and Drug Administration (FDA) has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W.

The Menveo one-vial presentation now comes in a ready-to-use single vial giving healthcare providers a more convenient option. The Menveo one-vial presentation will initially be available to US federal customers, with broader availability anticipated in mid-2023.

Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

The FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent vaccines to authorize their use as a single booster dose in younger age groups.

Both vaccines target the Omicron BA.4 and BA.5 subvariants.

• The Moderna COVID-19 bivalent vaccine is authorized for administration as a single booster dose at least 2 months following completion of primary or booster vaccination in children 6 years of age and older.
• The Pfizer-BioNTech COVID-19 bivalent vaccine is authorized for administration as a single booster dose at least 2 months following completion of primary or booster vaccination in children 5 years of age and older.

FDA approves Krazati (adagrasib) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation

The FDA has granted accelerated approval to Mirati Therapeutics’ Krazati (adagrasib), an oral KRAS G12C inhibitor, for the treatment of adult patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

In 2022, it is estimated that approximately 236,740 adults in the United States will be diagnosed with lung cancer, and NSCLC is thought to account for 82% of those lung cancer diagnoses. An estimated 13%–14% of patients with NSCLC are thought to harbor the KRAS G12C mutation, representing approximately 20,000 to 25,000 people in the United States. According to Amgen, as many as 66% of patients with NSCLC present with advanced or metastatic disease at initial diagnosis.

Krazati has demonstrated a positive benefit-risk profile with accelerated approval based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating Krazati 600 mg capsules administered orally twice daily in 116 patients with KRASG12C
-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor.

Also on December 12, 2022, the FDA approved Qiagen’s therascreen KRAS RGQ PCR kit and Agilent Technologies’ Resolution ctDx FIRST Assay as companion diagnostics for Krazati.

Krazati will directly compete with Amgen’s Lumakras (sotorasib), which was granted accelerated approval on May 28, 2021, for the same indication.

Mirati has priced Krazati at $240,000 per year; the estimated annual WAC for Lumakras is currently $231,000.

Read more…

The FDA has approved Furoscix (furosemide injection) a loop diuretic used for the at- home treatment of adults with congestion due to fluid overload in chronic heart failure.

scPharmaceuticals Inc., focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, announced that the U.S. Food and Drug Administration (FDA) has approved Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an on-body infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

Furoscix demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide. Furoscix is not indicated for emergency situations or in patients with acute pulmonary edema. The Furoscix infusion will last about 5 hours. Furoscix Infusor will deliver only an 80- mg dose. Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor.

The U.S. Food and Drug Administration on Friday allowed the use of GlaxoSmithKline’s (GSK.L) Boostrix vaccine during the third trimester of pregnancy to prevent whooping cough in infants younger than two months of age.

“When the Boostrix vaccine is given during pregnancy, it boosts antibodies in the mother, which are transferred to the developing baby,” the agency said.

While FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual, the latest decision expands its use to help prevent pertussis, commonly known as whooping cough, in infants younger than two months.

Alnylam has announced FDA approval of supplemental new drug application for Oxlumo (lumasiran) in advanced primary hyperoxaluria type 1.

The leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved a label expansion for Oxlumo^® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients.

Oxlumo is administered once a month for three months, then monthly for patients weighing less than 10 kg, and quarterly for patients weighing more than 10 kg.

The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.