Rx Products News: September 2022

Atogepant (Qulipta)

Manufactured by AbbVie

AbbVie submitted a supplemental new drug application to the FDA for atogepant (Qulipta) to include the preventive treatment of chronic migraines in adults. If approved, the drug would be the first gepant approved for the broad indication of preventive treatment of chronic as well as episodic migraine. The application is based on data from the phase 3 PROGRESS trial (NCT03855137), which met its primary end point of statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in adults with chronic migraine. The trial also met all 6 secondary end points.

FOR MORE INFORMATION:

abbvie.com

Aflibercept (Eylea)

Manufactured by Regeneron Pharmaceuticals Inc

Regeneron Pharmaceuticals, Inc, said the FDA has accepted for review the aflibercept (Eylea) injection supplemental biologics license application for an every-16-week 2-mg dosing regimen, after initial monthly doses, in patients with diabetic retinopathy (DR). The drug was previously approved for the treatment of all stages of DR with a dosing regimen of 4 weeks and/or 8 weeks after 5 initial monthly doses. If approved, the extended dosing regimen could offer a potentially longer treatment interval. The application is supported by data from the phase 3 PANORAMA trial (NCT02718326)
that investigated an every-8-week and every- 16-week Eylea dosing regimens vs sham in patients with severe nonproliferative diabetic retinopathy. The study met its primary end point of proportion of individuals with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale score at 1 year.

FOR MORE INFORMATION:

regeneron.com

Nirmatrelvir and Ritonavir (Paxlovid)

Manufactured by Pfizer

The FDA revised the emergency use authorization (EUA) for nirmatrelvir and ritonavir (Paxlovid) to allow state-licensed pharmacists to prescribe it to eligible individuals with COVID- 19. The FDA originally granted EUA in December 2021 for high-risk individuals with COVID-19. For pharmacists to determine patient eligibility, patients who test positive for COVID-19 should bring an electronic or printed health record that is less than 12 months old, including the most recent report of laboratory blood work, and a list of all, including OTC, medications they are taking.

FOR MORE INFORMATION:

pfizer.com

Pneumococcal 15-Valent Conjugate Vaccine (Vaxneuvance)

Manufactured by Merck

The FDA has approved an expanded indication for the pneumococcal 15-valent conjugate vaccine (Vaxneuvance) to include infants, children, and adolescents aged 6 weeks through 17 years. Pneumococcal 15-valent conjugate vaccine is now indicated for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks and older. The approval was based on data from 7 double-blind, randomized clinical trials that evaluated the vaccine’s immunogenicity, safety, and tolerability. The results showed that the immune response produced by the 15-valent vaccine after a 4-dose pediatric series was noninferior to that produced by the 13-valent pneumococcal conjugate vaccine.

FOR MORE INFORMATION:

merck.com