During a meeting this week, an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed 10 new medicines for approval, including a diabetes drug from Sanofi (SNY) and a breast cancer drug from Eli Lilly (LLY)
In a press release on Friday, Sanofi (SNY) said the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Teizeild (teplizumab) as a treatment to delay the onset of a more severe form of type 1 diabetes in patients aged eight years and older.
The antibody therapy is already approved in multiple countries, including the U.S., for the age group to delay stage 3 T1D in patients with stage 2 T1D. If the European Commission approves CHMP’s views, Teizeildx could be the first disease-modifying therapy available in the EU for T1D.
Additionally, the company said following EMA feedback and the CHMP decision, it will not advance its marketing authorization application for Teizeildx targeting recently diagnosed stage 3 T1D.
EMA’s press release on the CHMP recommendation also indicated that Eli Lilly (LLY) has won the panel’s backing for its breast cancer therapy Inluriyo (imlunestrant).
Accordingly, the oral hormonal therapy will be available in the region pending EC approval as a late-line option for certain adults with estrogen receptor-positive, HER2-negative breast cancer with an activating ESR1-mutation.
Meanwhile, Ionis Pharma (IONS) and Otsuka (OTCPK:OTSKY) announced a positive CHMP opinion on thier MAA for Dawnzera, which paves the way for the drug’s EU approval for those with hereditary angioedema, a rare genetic disorder characterized by severe swelling.
The panel has endorsed Dawnzera’s use for routine prevention of recurrent HAE attacks in patients aged 12 years and older, pending a final decision from the European Commission expected in Q1 2026.