Teplizumab

The European Medicines Agency recommended 104 medicines for approval in 2025, the second-highest number in the past 15 years, according to a report the agency published Thursday. Of the positive recommendations last year, 38 were for new active substances — novel molecules, as opposed to reformulations or generics, for instance — according to the report. That figure markedly lags the 53 new treatments greenlit by the FDA in 2025. The total number was second only to the 114 drugs recommended in 2024. “If you look back over the past 15 years, you will see the number waxes and wanes, but there was a big dip during Covid-19,” EMA chief medical officer Steffen Thirstrup said in a press briefing on Thursday. “Some of what we saw [in 2024] was…a wave of things that had been postponed and protracted during Covid-19, and 104 is still a very high number of approvals from a European perspective.” Several new products were approved in the US last year but are still awaiting European authorization. These include Milestone Pharmaceuticals’ Cardamyst, approved in the US in December for an arrhythmia disorder called paroxysmal supraventricular tachycardia. Milestone has submitted an application in the EU for the drug under the name Tachymist, but a decision is not expected until the first quarter of 2027, showing just how long the delay between the two regulators can be. At least one product was approved in Europe but not in the US, however. The European agency recommended Novo Nordisk’s fixed-dose combination of insulin icodec and semaglutide for type 2 diabetes in September, and it was approved in Europe as Kyinsu in November. US approval of Kyinsu is not imminent. The FDA rejected insulin icodec due to manufacturing concerns in 2024. Novo has since resubmitted insulin icodec in the US, but will have to wait for that decision before filing the fixed-dose combination. As a combination of approved drugs, Kyinsu would not count as a novel medicine, however. Endocrinology was the most popular therapeutic area for medicine approvals in Europe last year. The EMA recommended 29 products for endocrine disorders, including three new treatments. These were Bayer’s Lynkuet for menopause symptoms, Sanofi’s Teizeild for type 1 diabetes and Amgen’s Tepezza for thyroid eye disease. Looking to the year ahead, the EMA said it expects continued innovation in weight management and diabetes. The agency has received the first application for a generic version of Novo Nordisk’s older GLP-1 agonist product liraglutide for both indications. Meanwhile, its safety committee is also looking into possible interactions between the drug class and contraceptive pills.

A number of drugs being reviewed by the FDA that have been awarded one of the new Commissioner's National Priority Vouchers (CNPVs) are facing delays in the regulatory process, pushing back potential approval, Reuters reported Thursday. Medicines facing hold ups include Boehringer Ingelheim's zongertinib, Disc Medicine's bitopertin, Eli Lilly's orforglipron and Sanofi's Tzield (teplizumab-mzwv).Launched amid much fanfare last June, the CNPV initiative aims to cut the timeline for reviewing drug and biologic marketing applications down to within a month or two, but only for companies that are "aligned with US national priorities," sparking questions over the legality, transparency and safety of CNPVs. Concerns over the programme are said to have been the reason why FDA veteran Richard Pazdur recently stepped down as director of the agency's Center for Drug Evaluation and Research (CDER).According to Reuters — citing internal documents it viewed — Sanofi's bid to expand approval of Tzield to adults and paediatric patients eight years of age and older recently diagnosed with stage 3 type 1 diabetes had an original decision date of November 21 last year. The anti-CD38 antibody had been awarded a CNPV on October 16, with the French drugmaker announcing a few days later that the FDA had accepted the filing for review.The documents seen by Reuters suggest that the agency has delayed its decision on Tzield due to a treatment-related death along with other adverse event reports, including two related to seizure and blood clotting. Earlier this week, Sanofi confirmed that its plans to seek expanded approval of the therapy in Europe to include recently diagnosed stage 3 type 1 diabetes have been placed on hold following discussions with the EMA, although no further details were provided.Meanwhile, Disc Medicine's bid for accelerated approval of bitopertin in erythropoietic protoporphyria, including X-linked protoporphyria — submitted last September — has also reportedly been delayed due to concerns about trial data and the GlyT1 inhibitor's risk for abuse. The Reuters report suggested a decision on the marketing application has been pushed back by two weeks to February 10.Internal documents cited by Reuters indicate the FDA has concerns over whether pain-free time in the sun — a secondary endpoint used in clinical trials of bitopertin — is a statistically robust measure of efficacy. In addition, agency staff responsible for scheduling drugs that have a potential for abuse or addiction are also looking at whether bitopertin poses any abuse risks.Delay for Lilly's oral obesity drug?Reuters also suggested that a decision on Lilly's submission seeking approval of its once-daily oral small molecule GLP-1 receptor agonist orforglipron for weight loss is expected by April 10, having been originally anticipated in late-March. A company spokesperson confirmed that, based on current FDA guidance, a decision could come in the second quarter.The timeliness of orforglipron's approval is important to Lilly, given that rival Novo Nordisk won the race to bring an oral obesity drug to market in the US, following FDA clearance of oral Wegovy (semaglutide) at the end of 2025. See - Vital Signs: Novo's oral Wegovy is priced to move and JPM26: Novo Nordisk, Eli Lilly trade blows on oral obesity aspirations.Reuters added that a decision on Boehringer Ingelheim's zongertinib in first-line HER2-mutated non–small-cell lung cancer (NSCLC) is currently expected in mid-February. The tyrosine kinase inhibitor gained accelerated approval as Hernexeos for unresectable or metastatic, second-line HER2-mutated, non-squamous NSCLC last August (for related analysis, see - Spotlight On: Boehringer looks to get jump on Bayer in first-line HER2-positive lung cancer race). In response to the Reuters report, Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said that while the FDA does not comment on applications that are under review, its divisions are allowed the flexibility to adjust time lines if required.