Novartis Receives Simultaneous Approval for Five Innovative Medicines in Japan: Tabrecta, Entresto, Mayzent, Enerzair, and Atectura
Jun 29, 2020 08:20
CST Updated
20:20
Novartis
Drug Development and Manufacturing
June 29, 2020 /Bio ValleyBIOON/ --Novartis(Novartis) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has simultaneously approved five drugs:
——Tabrecta(Capmatinib, formerly known as INC280): This drug is an oral MET inhibitor indicated for the treatment of patients with advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping (METex14) mutations.
——Entresto(Chinese brand name: Entresto, sacubitril/valsartan): Used for the treatment of chronic heart failure.
——Mayzent(Chinese brand name: Wanlineng; generic name: siponimod): indicated for the treatment of secondary progressive multiple sclerosis (SPMS).
——Enerzair(QVM149; indacaterol acetate/glycopyrronium bromide/mometasone furoate, indacaterol acetate/glycopyrronium bromide/mometasone furoate; IND/GLY/MF) andAtectura(QMF149, IND/MF, indacaterol acetate/mometasone furoate): For the treatment of different types ofAsthma。
NovartisKazunari Tsunaba, President and Representative Director of the pharmaceutical company, stated, “The simultaneous approval of five new products is a remarkable achievement for both Japan and our industry. We are delighted to see our innovative medicines receive support from leading regulatory authorities. All five drugs represent truly novel and transformative therapies, marking a significant milestone in our mission to reimagine medicine. I would like to thank our colleagues in Japan and around the world for their tremendous efforts in achieving this unprecedented milestone.”
Year-to-date, Novartis has secured approval for seven new products in Japan. In addition to today’s five approvals, the company also received approval in March for Zolgensma, a one-time gene therapy for spinal muscular atrophy (SMA), and Beovu, an anti-VEGF drug for wet age-related macular degeneration (wet AMD). These approvals, along with today’s unprecedented milestone, demonstrateNovartisthe overall strength of its innovative drug pipeline, as well as the company’s commitment to ensuring that patients in Japan have timely access to these life-changing therapies.” (Bioon.com)