Roche wins ex­panded EU ap­provals for Gazy­varo, Actemra

BioSpectrum (Asia) - - World News -

Roche re­ceived ex­panded Euro­pean ap­provals for its Actemra med­i­ca­tion in gi­ant cell ar­teri­tis (GCA) and for Gazy­varo in peo­ple with pre­vi­ously un­treated ad­vanced fol­lic­u­lar lym­phoma.

The medicines have been ap­proved in other set­tings for years, but Roche is push­ing to ex­pand or ac­cel­er­ate their use as the Swiss com­pany’s three main medicines, Avastin, Ri­tuxan and Her­ceptin, with $20 bil­lion in an­nual sales, come un­der threat of in­creas­ing com­pe­ti­tion from cheaper biosim­i­lar copies. In 2016, sales of Actemra rose 16 per cent to 1.7 bil­lion Swiss francs ($1.76 bil­lion) for pa­tients with rheuma­toid arthri­tis but are due to more than dou­ble be­tween now and 2024.

Sales of

Gazy­varo, a blood can­cer medicine Roche de­vel­oped to fol­low its block­buster Ri­tuxan that this year lost patent pro­tec­tion, rose 52 per cent to 196 mil­lion francs last year. While Gazy­varo has been ap­proved in Europe to treat fol­lic­u­lar lym­phoma as a sec­ond­line ther­apy in cases where Ri­tuxan failed, clear­ing this lat­est reg­u­la­tory hur­dle al­lows Roche to de­ploy the medicine as a first-line ther­apy for pa­tients just di­ag­nosed with the most com­mon form of nonHodgkin lym­phoma.

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