AstraZeneca scores orphan status for PD-L1/CTLA-4 combo; EMA OKs Novartis' MS drug Mayzent
→ AstraZeneca gained an orphan drug designation for its combination of Imfinzi and the CTLA-4 drug tremelimumab for hepatocellular carcinoma (HCC), the most common type of liver cancer. Orphan designations, which are all the rage, provide 7 years of exclusivity to manufacturers.
→ Novartis’ oral treatment for secondary progressive multiple sclerosis, Mayzent (known chemically as siponimod), was given the nod by the EMA on Monday, less than a year after its FDA approval. GlobalData expects global sales for Mazyent to reach approximately $1.8 billion in the seven major markets by the end of 2028. This is approximately half of the peak sales reached by Novartis’ other MS drug, Gilenya, since progressive MS is a smaller patient population compared to relapsing-remitting MS, the analysts said.
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