HIPRA SARS-CoV-2(Laboratorios HIPRA)

For Eisai and Biogen, the European Medicines Agency’s Committee for Medicinal Products for Human Use’s decision to stick by its previous call on Leqembi now punts the final approval verdict back to the European Commission, which is the ultimate authority on whether a drug scores marketing authorization in the EU. Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), drugmakers are celebrating a bevy of endorsements for big-name meds.Over the course of the sit-down, which ran from Monday through Thursday, the CHMP recommended four new drugs for approval, teed up another 16 potential label expansions and—in a major win for Eisai and Biogen—reaffirmed the positive opinion on the Alzheimer’s disease drug Leqembi (lecanemab) it first issued in November, according to the agency’s meeting summary Friday.For Eisai and Biogen, the CHMP’s decision to stick by its previous call now punts the final approval verdict for Leqembi back to the European Commission (EC), which is the ultimate authority on whether a drug scores marketing authorization in the EU.Despite Leqembi winning the CHMP’s favor in November—albeit in a somewhat restricted patient population—the European regulator last month said it would honor the EC’s request to consider new safety data on the antibody that surfaced after the initial thumbs-up, Biogen explained in a Friday press release.“The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified,” Biogen said of the situation last month. The CHMP has specifically backed Leqembi to treat mild cognitive impairment or mild dementia from Alzheimer’s but only for patients carrying one or no copy of the ApoE4 gene. Patients with two copies of the gene are at greater risk of brain swelling or bleeding side effects known as amyloid-related imaging abnormalities, according to trial data. Elsewhere, the CHMP this week advanced four new drugs for potential European approvals. Those are: Takeda’s immunoglobulin drug Deqsiga, Regeneron’s multiple myeloma antibody Lynozyfic, Krystal Biotech’s dystrophic epidermolysis bullosa gene therapy Vyjuvek and Accord Healthcare’s generic drug trabectedin, which has been endorsed in advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer.As for proposed label expansions, the CHMP endorsed new uses for drugs from Vertex, Novartis, AbbVie, Eli Lilly and many other companies.In Lilly’s case, the regulator recommended approval for the company’s BTK inhibitor Jaypirca to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) who’ve already tried another medication from the same class.In addition to the new positive opinion in CLL, the drug also boasts a conditional European nod in mantle cell lymphoma, Lilly noted in a press release.AbbVie, for its part, got the CHMP’s backing in its bid to expand Rinvoq’s reach into the inflammatory disease giant cell arteritis, while Novartis’ Fabhalta received the agency’s blessing to treat adults with C3 glomerulopathy (C3G). C3G is an ultrarare kidney disease—often striking when people are young—that currently lacks any approved treatment options, Novartis said Friday.Other major label expansions that passed muster with the CHMP include those for Vertex’s Kaftrio and Kalydeco in combination to treat cystic fibrosis patients 2 and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator gene, plus a bid to expand the use of Valneva’s chikungunya vaccine Ixchiq to provide active immunization for kids starting at age 12. Notably, several drugmakers withdrew applications from the CHMP.Sanofi, for example, pulled the plug on efforts to score a European label expansion for Dupixent to treat moderate to severe chronic spontaneous urticaria in adults and adolescents, according to the committee's update. Plus, Spanish biotech HIPRA withdrew the application for an adapted version of its COVID-19 vaccine Bimervax targeting an updated strain of the SARS-CoV-2 virus.