Approvals
Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
The approval makes Pfizer’s Hympavzi the first once-weekly subcutaneous prophylactic injection for hemophilia B in the U.S., according to the company, which is currently embroiled in a row with activist investor Starboard Value.
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.
Opdivo’s approval for patients with resectable non-small cell lung cancer comes as the regulator recently raised concerns of overtreatment with this type of therapeutic regimen with platinum-doublet chemotherapy.
Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection.
IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa.
With Friday’s approval, Sanofi’s anti-CD38 antibody Sarclisa will go head-to-head with the first such therapy for multiple myeloma, Johnson & Johnson’s Darzalex, which raked in nearly $10 billion last year.
With the FDA’s approval, Fasenra will compete with GSK’s Nucala, which in December 2017 became the first biologic approved for eosinophilic granulomatosis with polyangiitis.
The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.
PRESS RELEASES