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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