CHMP backs Lilly's oral GLP-1 Foundayo for EU approval

The EMA's human medicines committee, the CHMP, has recommended approval of Eli Lilly's oral GLP-1 agonist Foundayo for weight management and treatment of type 2 diabetes (T2D).

The decision puts Foundayo (orforglipron) on course to be the second oral GLP-1 agonist to reach the market in the EU after Novo's Wegovy (semaglutide) pill, which was approved in July for weight management only. The European Commission generally approves drugs recommended by the CHMP within a few weeks.

In the T2D indication, Foundayo will compete with Novo's Rybelsus brand of oral semaglutide, a $3 billion-plus blockbuster that has been on the market in the EU since 2020.

Rybelsus and Wegovy must be taken on an empty stomach after an overnight fast, with patients waiting at least 30 minutes before ingesting anything else, while Foundayo can be taken at any time of day, with or without food or water.

Assuming the Commission follows the CHMP's advice and approves Foundayo, it will open up a new front in a battle between Novo and Lilly for command of the oral GLP-1 agonist category, alongside their tussle for market shares in injectable incretin therapies for weight management and T2D.

Oral Wegovy is currently out in front, generating around $850 million in sales worldwide in the first half of this year, while Foundayo – which reached the market later – pulled in $98 million, all in the second quarter.

Market researchers estimate that oral therapies account for roughly a third of obesity prescriptions in the US, the most mature market, with Novo capturing more than 80% of new oral prescriptions, although Lilly is now well ahead in the injectables category.

Ascendis' new dwarfism drug

Along with a positive opinion for Revolution Medicines' much-anticipated pancreatic cancer drug Rasonque (daraxonrasib, see our article here), the CHMP also recommended approval of Ascendis Pharma's Yuviwel (navepegritide) for the treatment of achondroplasia – the most common form of dwarfism – in children.

Yuviwel is a once-weekly subcutaneous C-type natriuretic peptide (CNP) analogue that was approved in the US earlier this year and had been used to treat more than 220 patients in the first half of the year, bringing in revenues of €8 million for the Danish biopharma company. It is also being developed for another form of dwarfism called hypochondroplasia.

The drug will compete with the only CNP drug on the EU market at the moment, BioMarin's Voxzogo (vosoritide), which needs to be injected subcutaneously once daily.

Extended indications

The CHMP also recommended extensions to the approved indications for medicines already on the EU market, including:

• Johnson & Johnson's GPRC5D-targeting bispecific antibody Talvey (talquetamab) – alongside J&J/Genmab's Darzalex (daratumumab), with or without pomalidomide – after at least one prior therapy for relapsed or refractory multiple myeloma. Talvey was previously cleared as a fourth-line or later monotherapy for the blood cancer;
• Sobi's apoC-III inhibitor Tryngolza (olezarsen), in combination with other lipid-lowering therapies, for severe hypertriglyceridaemia, adding to its current indication in familial chylomicronaemia syndrome (FCS); and
• Pfizer's oral HER2 inhibitor Tukysa (tucatinib), in combination with anti-HER2 antibodies trastuzumab and pertuzumab, for maintenance treatment of locally advanced or metastatic HER2-positive breast cancer that cannot be treated with surgery, after induction chemotherapy.