Sanofi wins EU approval for Wayrilz to treat immune thrombocytopenia

Sanofi (EURONEXT: SAN) (NASDAQ: SNY) received European Commission approval for Wayrilz (rilzabrutinib) to treat immune thrombocytopenia in adults who are refractory to other treatments. The drug represents the first BTK inhibitor approved in the EU for this rare blood disorder.

The approval was based on the LUNA 3 phase 3 study, which included 202 adults with persistent or chronic ITP. Patients receiving Wayrilz achieved a statistically significant durable platelet response at week 25, with 23% of patients in the treatment arm versus 0% in the placebo arm meeting this endpoint.

The study showed Wayrilz patients experienced faster time to first platelet response at 36 days compared to the placebo arm where this endpoint was not reached. Patients also maintained platelet response for a longer duration, with a least square mean of 7 weeks versus 0.7 weeks for placebo.

Patients reported a 10.6-point improvement in overall quality of life compared to a 2.3-point increase in the placebo group, based on The Immune Thrombocytopenia Patient Assessment Questionnaire. The most common adverse reactions with an incidence of at least 10% were diarrhea, nausea, headache, abdominal pain, and COVID-19.

Wayrilz works as an oral, reversible BTK inhibitor that targets different pathways across the immune system. ITP is caused by complex immune system dysregulation that leads to low platelet counts below 100,000/μL, resulting in bleeding symptoms and increased thromboembolism risk.

The drug has previously received approval in the United States and United Arab Emirates, with regulatory reviews ongoing in Japan and China. It received fast track and orphan drug designations in the US for ITP, along with similar orphan designations in the EU and Japan.

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