Monthly Archives: June 2022

The U.S. FDA has issued a safety warning for Secura Bio’s Copiktra® (duvelisib), a treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

• Data from a recent clinical trial shows a possible increased risk of death and serious side effects with Copiktra compared to another medicine used to treat leukemia and lymphoma.
• The FDA advises patients and their healthcare providers to discuss the risks and benefits of Copiktra in the context of other possible treatment alternatives.
• First FDA approved in 2018, Copiktra is indicated to treat adults who have relapsed or refractory CLL and SLL after at least two prior therapies.

Drug manufacturer Alfasigma has withdrawn Zelnorm® (tegaserod) from the U.S. market. According to the company, the withdrawal is the result of a business decision and not based on the safety or efficacy of the drug.

• Zelnorm received FDA approval in 2002 to treat irritable bowel syndrome with constipation (IBS- C) in female patients. It was withdrawn from the market in 2007 due to concerns over increased risk of heart attack, stroke, and unstable angina.
• In 2019, Zelnorm was reintroduced to the U.S. marketing as a treatment for IBS-C in female patients under 65 years age.
• Zelnorm will remain available to patients until the current supply is exhausted. Several potential treatment alternatives are currently available in the U.S.

Based on recent data, the U.S. FDA has revised emergency use authorization (EUA) for

AstraZeneca’s Evuseld™ (tixagevimab co-packaged with cilgavimab).

• According to the FDA, data suggests that Evusheld retains activity for six months, when given at a dose of 300mg tixagevimab and 300mg cilgavimab, against the current prevalent Omicron subvariants of SARS-CoV-2, the virus that causes COVID-19. Therefore, the FDA now recommends repeating this dose once every six months in eligible individuals.
• Evusheld is authorized to prevent COVID-19 in adults and pediatric individuals (at least 12 years old and weighing at least 40kg, or 88 pounds) who are not currently infected with SARS-CoV-2, who have not had a known recent exposure to an individual infected with SARSCoV-2, and:
  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, or
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
• Evusheld first received EUA to prevent COVID-19 in 2021.

The U.S. FDA has approved two new indications for Breyanzi® (lisocabtagene maraleucel), in the treatment of large B-cell lymphoma (LBCL).

• Breyanzi is now approved to treat LBCL in adults who:
  • Have disease refractory to first-line chemoimmunotherapy or that has relapsed within 12 months of first-line chemoimmunotherapy; or
  • Are not eligible for hematopoietic stem cell transplant due to comorbidities or age and have disease refractory to first-line chemoimmunotherapy or that has relapsed after firstline chemoimmunotherapy.
• First FDA approved in 2021, Breyanzi is also indicated to treat relapsed or refractory LBCL in adults who have received two or more lines of systemic therapy.
• Recommended dosing is individualized, as Breyanzi is a CAR-T therapy made using the patient’s own immune cells.

Tafinlar® (dabrafenib) and Mekinist® (trametinib), both made by Novartis, are now approved for combination use to treat unresectable or metastatic solid tumors with BRAF V600E mutation in patients who are at least six years old and have disease progression following prior treatment, with no satisfactory alternative treatment options.

• Both medications have held FDA approval since 2013. They are indicated to treat multiple forms of cancer in patients who have a BRAF mutation.
• The recommended dosage of Tafinlar is 150mg twice daily for adults and based on body weight in children. Recommended dosing for Mekinist is 2mg once daily for adults and based on body weight in children. Both medications are taken by mouth at least one hour before or two hours after a meal.

The U.S. FDA has approved an expanded indication for Vaxneuvance™ (pneumococcal 15valent conjugate vaccine) to include pediatric patients.

• First FDA approved in 2021 to vaccinate adults, Vaxneuvance is now indicated to provide active immunization in patients at least six weeks of age to prevent invasive disease caused by fifteen specific variants of Streptococcus pneumoniae.
• Vaxneuvance is administered via intramuscular injection. The recommended dosing is:
  • Ages six weeks through 17 years: A series of four 0.5mL doses given at 2, 4, 6, and 12 through 15 months of age.
  • Ages 18 and up: A single 0.5mL dose.

Zulresso (brexanolone) has obtained an expanded indication to treat postpartum depression (PPD) in patients who are at least 15 years old.

• In 2019, the FDA approved Zulresso to treat PPD in adults. The drug is administered via intravenous infusion under the supervision of a qualified healthcare professional.
• A full course of treatment requires 60 hours and follows a recommended dosing schedule of:
  • 0 to 4 hours: Initiate with a dosage of 30mcg/kg of the patient’s weight per hour.
  • 4 to 24 hours: Increase dosage to 60mcg/kg/hour.
  • 24 to 52 hours: Increase dosage to 90mcg/kg/hour (or consider a dosage of 60mcg/kg/hour for individuals unable to tolerate 90mcg/kg/hour).
  • 52 to 56 hours: Decrease dosage to 60mcg/kg/hour.
  • 56 to 60 hours: Decrease dosage to 30mcg/kg/hour.

Skyrizi® (risankizumab-rzaa – AbbVie) is now the first and only specific interleukin-23 (IL23) inhibitor to receive FDA approval for treating moderately to severely active Crohn’s disease in adults.

• First FDA approved in 2019, Skyrizi is also indicated to treat active psoriatic arthritis and moderate to severe plaque psoriasis.
• The recommended starting dose for Crohn’s disease is 600mg administered by intravenous infusion at Weeks 0, 4, and 8 of treatment. Maintenance treatment begins at Week 12, with a recommended dose of 360mg administered by subcutaneous injection once every eight weeks.

Comirnaty® (COVID-19 vaccine, mRNA) and Spikevax® (COVID-19 vaccine, mRNA) have been granted emergency use authorization (EAU) to prevent COVID-19 in children who are at least six months of age. This expands the age group for which both vaccines are authorized.

• Comirnaty, made by Pfizer and BioNTech, previously held an EUA for use in children at least five years of age, and full FDA approval for adults and for adolescents ages 16 and up.
• Moderna’s Spikevax is FDA approved for adults ages 18 and up.
• For both vaccines, the recommended dosing for pediatric patients varies based on age and whether the patient has a compromised immune system. Patients may require a two-dose primary vaccination series, a three-dose primary vaccination series, or a two-dose primary vaccination series plus a booster shot.
• Comirnaty and Spikevax have been used to prevent COVID-19 in the U.S. since 2020.

The U.S. FDA has approved Imcivree® (setmelanotide – Rhythm Pharmaceuticals) to treat of obesity and control hunger in patients who are at least six years old and have Bardet-Biedl 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 POMC, PCSK1, or LEPR deficiency confirmed by genetic testing in which variants in POMC, PCSK1, or LEPR genes are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
• Bardet-Biedl syndrome is a rare, complex genetic disorder that can cause hyperphagia, an abnormally strong feeling of hunger or desire to eat. Hyperphagia 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. Imcivree is administered by subcutaneous injection.