Oral Wegovy backed by CHMP at May meeting
In a packed programme, the EMA's human medicines committee recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral formulation of GLP-1 agonist Wegovy for weight loss.
The decision by the CHMP sets up a full EU approval of the first drug in the oral GLP-1 class in the next few weeks and keeps Novo Nordisk a step ahead of its nearest rival in the category, Eli Lilly, which isn't expected to launch its Foundayo (orforglipron) pill in Europe until 2027.
Novo Nordisk maintains that the Wegovy pill provides best-in-class efficacy in the oral category, and said it plans to launch the new drug in "select markets" outside the US, its first and so far only market, in the latter half of this year. The company has reported that the Wegovy pill launch is the strongest of any GLP-1-based weight-loss product to date, bringing in sales of $355 million in the first quarter of 2026.
And in a second piece of good news for Novo Nordisk, which is fighting to stay in contention with Lilly in the fast-growing GLP-1 category, the CHMP also gave its blessing to its new high-strength version of Wegovy injection in a single-dose pen.
The high-dose version is already approved in the EU in a vial formulation under the Wegovy HD brand name, and is another important line extension for Novo Nordisk as it tries to protect its weight-loss franchise from Lilly's rival injectable Zepbound/Mounjaro (tirzepatide).
CHMP round-up
Other highlights of the positive opinions adopted by the EMA committee at the May meeting include:
- Boehringer Ingelheim's Jascayd (nerandomilast), backed for the treatment of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), becomes the first new therapy for life-threatening lung conditions in more than a decade. The oral phosphodiesterase (PDE) 4B inhibitor is a successor to Boehringer's blockbuster therapy Ofev (nintedanib), which contributed €3.8 billion of its €27.8 billion revenues in 2025, and was approved in the US last October. Ofev is due to start losing patent protection from 2029 onwards.
- AstaZeneca's Etcamah (camizestrant) has been recommended for the frontline treatment of adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer with a specific mutation in the ESR1 gene, shortly after an FDA advisory committee voted against the drug's approval in the US. The drug is an oral selective oestrogen receptor degrader or SERD, and there are two approved drugs in this class in the EU – Menarini/Stemline's Orserdu (elacestrant) and Eli Lilly's Inluriyo (imlunestrant) – which are both approved for second-line use in patients with this form of breast cancer.
- Novartis' PI3Kα inhibitor Vijoice (alpelisib) got a green light for a new indication, treating severe PIK3CA-related overgrowth spectrum (PROS) disorders, to go alongside its current use in breast cancer, where it is facing strong competition from Roche's rival PI3Kα-targeting drug Itovebi (inavolisib). There is currently no authorised medicine in the EU for PROS, a diverse group of rare genetic conditions characterised by uncontrolled growth of certain tissues in the body, which are typically treated with surgery and procedures to block overgrown blood vessels.
