EMA com­mit­tee con­di­tion­ally ap­proves Ab­bVie leukemia drug

Kuwait Times - - HEALTH & SCIENCE -

Ab­bVie Inc won the con­di­tional back­ing of an ad­vi­sory com­mit­tee of the Euro­pean Medicines Agency (EMA) on Fri­day for a drug to treat a form of blood cancer.

The tablet, ven­clyxto, or vene­to­clax, is aimed at chronic lym­pho­cytic leukemia (CLL) pa­tients with ei­ther 17p gene dele­tion or TP53 mu­ta­tion, which are mark­ers for a par­tic­u­larly ag­gres­sive form of the dis­ease.

Ab­bVie said pa­tients with th­ese mark­ers have a me­dian life ex­pectancy of less than two to three years. The EMA grants con­di­tional ap­proval for drugs that fill an un­met med­i­cal need for se­ri­ous con­di­tions and show early ev­i­dence of clin­i­cal ben­e­fits out­weigh­ing the risks. Ven­clyxto, de­vel­oped by Ab­bVie and Roche Hold­ing AG, was ap­proved by the US Food and Drug Ad­min­is­tra­tion in April to treat the dis­ease. Ab­bVie will mar­ket the drug out­side the United States, while both com­pa­nies will sell it in the coun­try un­der the brand name Ven­clexta.

Cancer has been a fo­cus area for Ab­bVie as it looks to re­duce de­pen­dence on its arthri­tis treat­ment Hu­mira, the world’s topselling drug. As part of the strat­egy, Chicago-based Ab­bVie bought pri­vately held Stem­cen­trx and its ex­per­i­men­tal treat­ment for small-cell lung cancer in April for $5.8 bil­lion. Shares in Ab­bvie were un­traded pre­mar­ket at 1300 GMT.


NEW YORK: A screen dis­plays the share price for phar­ma­ceu­ti­cal maker Ab­bVie on the floor of the New York Stock Ex­change.

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