FDA hands down par­tial hold for Sun Phar­ma's alope­cia JAK can­di­date

The FDA has no­ti­fied Sun Phar­ma that the IND for its new­ly-ac­quired alope­cia can­di­date is un­der par­tial clin­i­cal hold af­ter a pa­tient ex­pe­ri­enced a blood clot in the lung.

The In­di­an drug­mak­er di­vulged the news in a let­ter Tues­day to two dif­fer­ent stock ex­changes in In­dia, say­ing that it learned about the hold af­ter a tele­con­fer­ence with the FDA.

A pa­tient suf­fered a pul­monary em­bolism, cat­e­go­rized as a se­ri­ous ad­verse event, while on 12 mg of deu­rux­oli­tinib, a se­lec­tive oral JAK1 and JAK2 in­hibitor that is tak­en twice a day. The pa­tient was en­rolled in a long-term, open-la­bel ex­ten­sion tri­al as­sess­ing the treat­ment in pa­tients with alope­cia, an au­toim­mune dis­or­der that caus­es hair loss.

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