Mepolizumab

The CHMP backing sets depemokimab up for an official approval by the European Commission in the first quarter of 2026, GSK said. GSK’s depemokimab, a long-acting biologic that’s key in the British pharma’s growth plan, has won European regulatory approval for two inflammatory disease indications.The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has backed depemokimab as an add-on maintenance treatment for severe asthma with type 2 inflammation in patients 12 years and older who are not adequately controlled by corticosteroids plus another asthma med. The drug is also recommended for use as an add-on therapy with intranasal corticosteroids to treat inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).The CHMP backing sets depemokimab up for an official approval by the European Commission, which GSK said is expected in the first quarter of 2026. Should it be approved, the twice-yearly IL-5 antagonist will bear the commercial moniker Exdensur. The FDA is also slated to make a decision on GSK’s application by Dec. 16.GSK has high hopes for the long-acting drug, having pegged depemokimab's peak-year sales at 3 billion pounds sterling ($4 billion). In Europe, roughly three million people live with severe asthma, and patients with CRSwNP face poorly controlled symptoms, according to GSK’s estimate. “Today’s positive CHMP opinion means that depemokimab could become the first and only ultra-long-acting biologic approved in Europe for the treatment of severe asthma with type 2 inflammation and CRSwNP,” Kaivan Khavandi, GSK’s global head of respiratory, immunology and inflammation R&D, said in a Dec. 12 statement. “In just two doses a year, depemokimab could help redefine care for millions of patients.”The main evidence supporting depemokimab in severe asthma comes from two replicate phase 3 trials, Swift-1 and Swift-2. The trials showed depemokimab significantly reduced exacerbation and hospitalization when added on top of corticosteroids plus at least another asthma controller.Across the two trials, nearly 800 patients were randomized. The annualized rate of exacerbations was 0.46 for the depemokimab recipients and 1.11 with placebo in Swift-1. Those rates worked out to 0.56 and 1.08, respectively, in Swift-2. Combined, the two trials linked depemokimab to a 54% reduction in asthma attacks over one year, according to a pooled analysis.Similarly, the CRSwNP indication is also based on two parallel phase 3 trials, Anchor-1 and Anchor-2, in which depemokimab was superior to placebo—both in addition to standard of care—in the endoscopic nasal polyps score and nasal obstruction verbal rating score.In addition to depemokimab, the CHMP also supported a label expansion for GSK’s monthly IL-5 biologic Nucala in chronic obstructive pulmonary disease (COPD). A formal EC nod is expected to clear the drug as an add-on maintenance therapy for patients whose disease remains uncontrolled despite being on inhaled triple therapies. The indication was already approved by the FDA in May.  In the Matinee study that won Nucala its COPD backings from the regulators, the drug showed a 21% reduction in the annualized rate of moderate or severe exacerbations compared with placebo when both were added to inhaled triplets.In a triple win for GSK with the CHMP this week, European drug reviewers also opined that the British pharma’s respiratory syncytial virus vaccine, Arexvy, can be used in all adults rather than for certain older populations alone. Elsewhere, the committee recommended granting a conditional marketing authorization for ImmunityBio’s Anktiva, used in tandem with BCG, in BCG-unresponsive non-muscle invasive bladder cancer that’s at high risk of growing and spreading. The recommendation is based on results from a single-arm trial of 100 patients showing a 71% complete response rate for the Anktiva-BCG regimen, with the responses lasting for about 27 months on average.As part of a conditional nod, ImmunityBio has committed to following the patients longer.“With the United States’ new Most-Favored-Nation Prescription Drug Pricing policy now in effect, we are thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access,” ImmunityBio CEO Richard Adcock said in a Dec. 12 release.Also receiving recommendations for approvals from the CHMP this week are Hansoh Pharma’s third-generation EGFR tyrosine kinase inhibitor, Aumseqa (aumolertinib), in EGFR-mutated non-small cell lung cancer; Cytokinetics’ challenger to Bristol Myers Squibb’s Camzyos, Myqorzo (aficamten), in obstructive hypertrophic cardiomyopathy; and Moderna’s second-generation COVID-19 vaccine, mNEXSPIKE.Merck & Co.’s pulmonary arterial hypertension med Winrevair, Eli Lilly’s diabetes drug Mounjaro and Bayer’s Regeneron-partnered high-dose Eylea were also among those that received CHMP endorsements for various label expansions.Meanwhile, the CHMP declined to back Anavex Life Sciences’ Alzheimer’s disease candidate blarcamesine. After the committee flagged a negative trend vote in November, Anavex said it will request a reexamination.

As part of a batch of recommendations issued Friday, the European Medicines Agency’s human medicines committee (CHMP) recommended rejecting Anavex’s Alzheimer’s disease drug, issuing a scathing review of the pill’s safety and efficacy issues. The committee said it was concerned that the pill, called blarcamesine, could contain cancer-causing impurities. In addition, its main clinical study failed to meet its objective, and a “high proportion of patients” stopped taking the drug because of central nervous system side effects. Last month Anavex said it planned to request a reexamination of blarcamesine from the European regulators, after CHMP warned a negative opinion was likely. Anavex has 15 days to file for reexamination. As part of Friday’s package of actions, the committee also recommended five new medicines and 10 label expansions. GSK secured a positive opinion for its RSV vaccine Arexvy to be expanded to patients 18 years or older, rather than its previous approval for just people aged 50 or over. Arexvy was approved by the European Medicines Agency in June 2023. This brings the RSV vaccine to an equal footing with its competitors: Pfizer’s Abrysvo and Moderna’s mResvia, which have both already been approved for adults aged 18 or older. GSK’s Exdensur also got a positive CHMP opinion for adults and adolescents 12 years and older with severe eosinophilic asthma as well as for severe chronic rhinosinusitis with nasal polyps. Depemokimab is currently under review by the FDA, with a PDUFA date of Dec. 16. CHMP gave a positive opinion for four other new medicines: CHMP recommended nine other label expansions: