The European Medicines Agency’s human-medicines committee has recommended approval of Eli Lilly’s orforglipron (Foundayo), a once-daily, non-peptide GLP-1 tablet for obesity and type 2 diabetes. It also recommended Revolution Medicines’ daraxonrasib (Rasonque), an oral drug that targets the RAS protein behind most pancreatic cancers. Both are among six new medicines recommended this month. India’s regulatory experts have already backed orforglipron, and Lilly has said an Indian launch could come in 2027.
For a decade, the medicines that transformed obesity treatment have mostly been injections. On Friday 16 October, the European Medicines Agency (EMA) published the highlights of its Committee for Medicinal Products for Human Use (CHMP) meeting of 12–15 October. The committee recommended a tablet that works in a similar way to those injections, and a first-in-class pill for one of the deadliest cancers.
Both recommendations now go to the European Commission, which makes the legally binding decision, usually within weeks. A CHMP opinion is not yet a marketing authorisation.
Orforglipron: why a small molecule matters
Semaglutide (sold as Ozempic and Wegovy) and tirzepatide (Mounjaro) imitate gut hormones, chiefly glucagon-like peptide-1 (GLP-1), that regulate appetite and blood sugar. They are peptides: chains of amino acids that are broken down in the stomach. They must therefore be injected or, in the case of oral semaglutide, taken with strict fasting rules so that enough survives absorption.
Orforglipron is different. It is a small-molecule, non-peptide GLP-1 receptor agonist: a conventional chemical drug that activates the same receptor but survives digestion. The EMA says Foundayo “will be available as a tablet taken once daily”, offering an alternative to injectable and other oral GLP-1 medicines. Lilly says it can be taken without food or water restrictions.
The practical advantages are significant. Small molecules are generally cheaper and simpler to manufacture at scale than peptides. Tablets do not need refrigeration or injection pens. Both points matter in countries with weak cold chains and very large numbers of patients.
The evidence and the indication
The CHMP recommended Foundayo for weight management in adults with a body-mass index (BMI) of at least 30 kg/m². It is also recommended for adults with a BMI of at least 27 who have at least one weight-related condition, such as prediabetes or type 2 diabetes, high blood pressure, abnormal blood lipids, obstructive sleep apnoea or cardiovascular disease, alongside diet and exercise. It was also recommended for adults with type 2 diabetes that is not adequately controlled.
In Lilly’s 72-week ATTAIN-1 trial of 3,127 participants, people taking the highest dose lost an average of 12.4% of body weight, against 0.9% on placebo, among those who stayed on treatment. On an analysis that counts everyone regardless of adherence, the figures were 11.1% and 2.1%. These are company-reported results. They are lower, on average, than the weight loss reported for injectable semaglutide and tirzepatide in their pivotal trials, although trials differ in design and population. The most common side effects are gastrointestinal: nausea, vomiting and diarrhoea.
The US Food and Drug Administration approved Foundayo for obesity on 1 April 2026. In the EU it would follow Novo Nordisk’s oral Wegovy, approved in July 2026, as the second oral GLP-1 medicine for weight management.
Daraxonrasib: drugging the “undruggable”
The second recommendation may prove more important scientifically. Mutations in the KRAS gene drive more than 90% of pancreatic ductal adenocarcinomas. For decades, RAS proteins were called “undruggable” because their smooth surface offered few places for a drug to bind. Earlier drugs such as sotorasib and adagrasib target a single mutation, KRAS G12C, which is rare in pancreatic cancer.
Daraxonrasib takes a different route. It is a tri-complex RAS(ON) multi-selective inhibitor. It binds a cellular helper protein, cyclophilin A, and the resulting complex then latches onto the active, “ON” form of several RAS variants and blocks their signalling.
The EMA recommends Rasonque for adults with metastatic pancreatic adenocarcinoma who have already had at least one treatment. In the phase 3 RASolute 302 trial, reported by Revolution Medicines, median overall survival was 13.2 months against 6.7 months with chemotherapy (hazard ratio 0.40). Median progression-free survival was 7.2 against 3.6 months. For a cancer in which second-line options are poor, a near doubling of median survival is a large effect. The EMA had designated the drug a “high-priority medicine” under its Cancer Medicines Pathfinder and reviewed it in phases. The FDA approved daraxonrasib in August 2026.
The rest of the list
The CHMP also recommended:
- Navepegritide (Yuviwel), a once-weekly treatment for achondroplasia in children
- A hybrid temozolomide product (Kizfizo) for brain tumours
- Biosimilars of ranibizumab (Fovlussea) and filgrastim (Neuzafy)
It also backed extensions of indication for medicines including AstraZeneca’s H5N1 pandemic influenza vaccine and Novo Nordisk’s insulin icodec–semaglutide combination (Kyinsu).
What it means for India
India has one of the world’s largest populations living with type 2 diabetes, and obesity is rising quickly. Its GLP-1 market changed in March 2026, when semaglutide’s Indian patent expired. Generic injectable versions from Sun Pharma, Dr Reddy’s, Zydus, Glenmark and others launched at a fraction of the earlier branded price, with some weekly doses priced at a few hundred rupees.
Orforglipron is already moving through Indian regulation. In June 2026, according to Medical Dialogues, CDSCO’s Subject Expert Committee recommended permission for Lilly to import and market orforglipron tablets. It required prescription by an endocrinologist or internal-medicine specialist and a phase 4 study. Lilly’s chief executive, David Ricks, said in early October that an Indian launch could come in 2027, subject to regulatory clearance. NSH has not found confirmation of final DCGI approval or Indian pricing.
The tablet will compete in India with cheap generic injections. Its appeal will depend on price, whether patients prefer a pill, and how well it is tolerated. Daraxonrasib has no announced Indian filing. For Indian patients with pancreatic cancer, access to such therapies is likely to depend on future filings and cost.
Caveats
Both recommendations rely heavily on company-sponsored trials. The trial figures quoted here are from company and trial reports, not the EMA’s assessment reports, which have not yet been published. Long-term data on orforglipron’s cardiovascular outcomes and safety are still being gathered.
