During a meeting this week, an expert panel of the EU drug regulator, the European Medicines Agency (EMA), has endorsed two new drugs from Sanofi (NASDAQ:SNY) and Insmed (NASDAQ:INSM) for authorization in the region.
EMA’s Committee for Medicinal Products for Human Use (CHMP) convened for its October 2025 meeting from Oct. 13 to Oct. 16. In addition to endorsing approvals, the committee rejected a new drug from Sanofi (NASDAQ:SNY) and recommended eight new label expansions.
Issuing meeting highlights on Friday, the EMA said that Sanofi (NASDAQ:SNY) has received CHMP’s positive opinion for its Bruton’s tyrosine kinase inhibitor—Wayrilz (rilzabrutinib) as a late-line treatment for immune thrombocytopenia, an immune-mediated disease characterized by bleeding.
The decision is based on the French drugmaker’s pivotal LUNA 3 phase 3 study, which met both primary and secondary endpoints, Sanofi (SNY) said.
Meanwhile, Insmed (NASDAQ:INSM) has received CHMP backing for its once-daily, oral therapy Brinsupri as a treatment for patients aged 12 years and above with non-cystic fibrosis bronchiectasis, a lung disease.
If approved by the European Commission (EC), which is set to review the CHMP recommendations next, Brinsupri will be the first treatment indicated in the region for non-cystic fibrosis bronchiectasis.
However, Sanofi (SNY) failed to secure a positive opinion for its marketing authorization application for Rezurock in chronic graft-versus-host disease (cGVHD), a complication of stem cell transplant.
Noting that Rezurock is already available in more than a dozen countries, including the U.S., Sanofi (SNY) said that CHMP’s decision was disappointing, and the company will seek a reexamination of the decision.
“We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting,” said Olivier Charmeil, Sanofi’s Executive Vice President, General Medicines.
As for label expansions, Roche (OTCQX:RHHBY) received CHMP backing for its antibody therapy Gazyva (Gazyvaro), marketed with Biogen (BIIB), as a treatment for adults with certain forms of lupus nephritis, a kidney disorder.
Regeneron (NASDAQ:REGN) is on track to receive EU approval for its PD-1 immune checkpoint inhibitor Libtayo, as the CHMP backed its use as an adjuvant therapy for adults with cutaneous squamous cell carcinoma following surgery and radiation.
Having received U.S. FDA approval for the drug against the same indication earlier this month, the New York-based biotech said that the European Commission is expected to make a final decision on its marketing authorization over the next few months.
Meanwhile, Agios (AGIO) has received a positive opinion for a new indication for its oral pyruvate kinase activator Pyrukynd (mitapivat) as a treatment for adults with anemia associated with alpha- or beta-thalassemia.
Other companies winning endorsements for label expansions included Bristol-Myers Squibb (BMY), Pfizer (PFE), J&J (JNJ), and Novartis (NVS).