Monthly Archives: April 2022

The U.S. FDA has approved Imcivree® (setmelanotide) for treatment of obesity and control of hunger in patients who are at least six years old and have Bardet-Biedl syndrome or Alström syndrome.

• Imcivree first received FDA approval in 2020. It is also indicated for chronic weight management in patients at least six years old who have obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
• Bardet-Biedl syndrome and Alström syndrome are rare, complex genetic disorders that can have a wide range of symptoms. These symptoms can include hyperphagia, an abnormally strong feeling of hunger or desire to eat, which can lead to obesity and may be present as early as the patient’s first year of life.
• Recommended dosing under the new indication is based on the patient’s age, renal health, and clinical response to treatment. Daily dosing can range from 0.25mg to 3mg administered via subcutaneous injection. Imcivree can be self-administered or administered by a caregiver once the individual has been trained in proper technique.

Amneal has received FDA approval for Alymsys® (bevacizumab-maly) intravenous injection, a biosimilar to Genentech’s Avastin® (bevacizumab).

• Alymsys is approved to treat certain patients who have colorectal cancer, non-squamous non- small cell lung cancer, glioblastoma, renal cell carcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Unlike Avastin, Alymsys is not indicated to treat hepatocellular carcinoma. It is also more limited in its approved use for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Recommended dosing is based on the indication. Alymsys is not approved to be automatically interchangeable with Avastin.
• Launch and pricing information have not been Alymsys is the third Avastin biosimilar to receive FDA approval, with Amgen’s Mvasi® (bevacizumab-awwb) approved in 2017 and Pfizer’s Zirabev® (bevacizumab-bvzr) approved in 2019.

Xigduo® XR (dapagliflozin/metformin) has received a new indication for one of its active pharmaceutical ingredients (APIs), dapagliflozin, to reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults who have chronic kidney disease at risk of progression.

• Xigduo XR’s other API, metformin, is indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Dapagliflozin holds two additional indications to reduce the risk of:
  • Hospitalization for heart failure in adults who have type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
  • Cardiovascular death and hospitalization for heart failure in adults who have heart failure (NYHA class II-IV) with reduced ejection fraction.
• Due to the metformin component, Xigduo XR should only be used in the treatment of adults who have type 2 diabetes. The FDA first approved Xigduo XR in 2014.
• Recommended dosing is based on a variety of factors, such as the patient’s current treatment regimen and treatment effectiveness and tolerability. Xigduo XR is taken by mouth once daily in the morning with food.

ArmonAir® Digihaler® (fluticasone propionate) has received an expanded indication to provide maintenance treatment (as prophylactic therapy) for asthma in patients who are at least four years old.

• First approved in 2020, ArmonAir Digihaler was initially indicated for patients at least 12 years The active pharmaceutical ingredient, fluticasone propionate, has been FDA approved since 1994.
• The FDA also approved a new ArmonAir Digihaler 30mcg dosage strength for the younger pediatric Recommended dosing under the expanded indication is determined by the patient’s age and severity of disease:
  • Patients 12 years and older: One 55mcg, 113mcg, or 232mcg dose taken twice daily by oral inhalation.
  • Patients 4-11 years old: One 30mcg or 55mcg dose taken twice daily by oral inhalation.

Novartis has obtained FDA approval for Vijoice® (alpelisib) to treat severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in patients at least two years of age who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS.

• PROS describes a range of rare disorders caused by mutations of the PIK3CA The mutations lead to overgrowth in various parts of the body and can cause severe complications.
• Vijoice addresses the root cause of PROS by inhibiting the PIK3 pathway. The recommended dosing is 50mg once daily for pediatric patients and 250mg once daily for adults. Vijoice is taken by mouth with food.
• Novartis also markets alpelisib, the active pharmaceutical ingredient of Vijoice, under the brand name Piqray®. Piqray has been FDA approved since 2019 for use in combination with fulvestrant to treat males and postmenopausal females who have HR-positive, HER2-negative, PIK3CA- mutated advanced or metastatic breast cancer that has progressed on or after an endocrine- based regimen.
• The wholesale acquisition cost (WAC) for Vijoice is $32,500 per Each carton provides a 28- day supply of medication.

Igalmi™ (dexmedetomidine) sublingual film, made by BioXcel Therapeutics, has received FDA approval to treat agitation associated with schizophrenia or bipolar I or II disorder in adults.

• According to the manufacturer, “Igalmi is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a ” The active pharmaceutical ingredient is the same as in Hospira’s Precedex®, an FDA-approved intravenous medication used to provide sedation in clinical settings.
• Under the prescribing information, Igalmi can be given in three doses, each spaced two hours apart, in one 24-hour The number of doses and total daily dose are determined by factors that include:
  • The severity of agitation;
  • Whether the patient has hepatic impairment;
  • Whether the patient is over or under 65 years of age;
  • The patient’s blood pressure and heartrate; and
  • The patient’s treatment
• Igalmi should be used under the supervision of a healthcare provider, and patient vital signs and alertness should be monitored by a healthcare provider following administration. It is given by buccal (placed against the inside of the cheek and allowed to dissolve) or sublingual (placed under the tongue and allowed to dissolve) administration.
• BioXcel plans to launch the product during the second quarter of 2022.

Several years following FDA approval, Ibsrela® (tenapanor) oral tablets are now available to treat irritable bowel syndrome with constipation (IBS-C) in adults.

• Ibsrela is a first-in-class treatment for IBS-C that received FDA approval on September 12, 2019. However, manufacturer Ardelyx has only recently launched the product.
• Recommended dosing is 50mg taken twice daily by mouth: once immediately prior to breakfast or the first meal of the day, and once immediately prior to dinner.
• The wholesale acquisition cost (WAC) is $1,500 per 60 tablets.

• Zoladex (goserelin implant) – for prostate cancer, breast cancer, and endometriosis

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Send a Report Via U.S. Mail or Fax: Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

Gilead’s Yescarta® (axicabtagene ciloleucel) has been approved to treat adults diagnosed with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

• Originally FDA approved in 2017, Yescarta is a chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T treatments are created by modifying a donation of the patient’s own T-cells, a type of immune cell, to target cancer. Dosing varies per patient.
• Yescarta is also indicated to treat relapsed or refractory large B-cell lymphoma or follicular lymphoma in adults who have had two or more lines of systemic therapy.

ViiV Healthcare’s Triumeq PD® (abacavir/dolutegravir/lamivudine) has been approved to treat HIV-1 infection in children who weigh 10kg (22 pounds) to less than 25kg (55 pounds).

• Triumeq PD is a new oral tablet for suspension that contains the same active pharmaceutical ingredients as ViiV Healthcare’s Triumeq® oral tablets.
  • Triumeq first received FDA approval in
  • Previously approved only for patients weighing at least 40kg (88 pounds), Triumeq is now indicated for patients who weigh at least 25kg.
  • Triumeq and Triumeq PD cannot be interchanged on a milligram per milligram basis due to differences in how the products move through the body.
• Recommended dosing is as follows:
  • Triumeq PD: Four to six tablets taken once daily, based on the patient’s weight. The oral tablets for suspension must be fully dispersed in 20mL of drinking water in a cup supplied with the medication. Triumeq PD is not recommended for adults or for children who weigh at least 25kg.
  • Triumeq: One tablet taken by mouth once Triumeq is recommended for adults and for children who weigh at least 25kg.
• Triumeq PD has launched at a wholesale acquisition cost (WAC) of $1,001.72 for 90 tablets.