On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Sanofi SA’s (NASDAQ:SNY) Rezurock (belumosudil).
The French drug maker was seeking approval for Rezurock for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD).
cGVHD is considered one of the leading causes of morbidity and late non-relapse mortality after stem cell transplant. Sanofi will seek a re-examination of the CHMP opinion.
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"We are disappointed by the negative CHMP opinion for Rezurock in the EU…," said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi.
Safety and efficacy results from several clinical studies and real-world evidence support Rezurock.
This includes the randomized, multicenter ROCKstar phase 2 study, which demonstrates consistent efficacy and tolerability for patients living with cGVHD after stem cell transplant and durable clinical responses over three years.
Rezurock is currently approved in 20 countries, including the US, UK, and Canada, for patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy and in China after failure of one prior line of systemic therapy.
More than 17,000 patients living with cGVHD worldwide have been prescribed Rezurock since its first approval in the US in July 2021.
Positive CHMP Opinion for Wayrilz (rilzabrutinib)
Concurrently, the CHMP adopted a positive opinion recommending the approval of Wayrilz (rilzabrutinib) as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
The positive CHMP opinion is based on the pivotal LUNA 3 phase 3 study. Wayrilz met the primary and secondary endpoints, making LUNA 3 the first phase 3 study to show a positive impact on sustained platelet counts, bleeding, and other ITP symptoms.
Price Action: SNY stock was trading higher by 0.98% to $50.51 at last check Friday.
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