Shots:
- Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier
- In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the treatment of non–cystic fibrosis bronchiectasis
- October 2025 marked the approval of two new therapies in the EU, matching the two approvals granted by the US FDA during the same month, signalling continued global momentum in bringing advanced treatments to patients
Company: Sanofi
Product: Wayrilz
Active Ingredient: Rilzabrutinib
Disease: Immune Thrombocytopenia
Date: Oct 16, 2025
Shots:
- The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
- Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week safety follow-up or long-term extension period. Trail met its 1 & 2EPs, Presented in the ASH’24 & published in the Blood
- Wayrilz is a BTK inhibitor for ITP, targeting the disease’s root cause through multi-immune modulation. It’s approved in the U.S. for adults with persistent or chronic ITP unresponsive to prior treatment
Company: Insmed
Product: Brinsupri
Active Ingredient: Brensocatib
Disease: Non-Cystic Fibrosis Bronchiectasis
Date: Oct 16, 2025
Shots:
- The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos.
- Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had ≥2 documented pulmonary exacerbations in 12mos. prior to screening, both published in the NEJM
- Brinsupri is a QD, oral DPP1 inhibitor approved in the US for treating NCFB pts (≥12yrs.). It targets neutrophil serine proteases to reduce airway inflammation and is also being studied for other neutrophil-driven diseases
Related Post: Insights+: EMA Marketing Authorization of New Drugs in September 2025
