Novartis Receives Approval for Five Products from Japanese Ministry of Health

Novartis Pharma announced the Japanese Ministry of Health, Labour and Welfare (MHLW) approved five new treatment options for Japanese patients:

• Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC),

• Entresto® (sacubitril valsartan sodium hydrate) in chronic heart failure,

• Mayzent® (siponimod fumaric acid) in secondary progressive MS,

• Enerzair™ (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and

• Atectura®  (indacaterol acetate, mometasone furoate) in different forms of asthma

“The simultaneous approval of five new products is remarkable for Japan and our industry. We are pleased to see that our innovative products gain the support from leading regulatory bodies”, said Kazunari Tsunaba, Representative Director and President of Novartis Pharma. “All five medicines are truly novel and transformative treatments and therefore mark an important milestone in our mission to reimagine medicine. I would like to thank our Japanese and global colleagues for all their dedication to make this unprecedented milestone happen."

To date, Novartis has received seven new product approvals in Japan this year. In addition to today's five approvals, in March, Novartis was granted marketing authorizations for spinal muscular atrophy treatment Zolgensma and for Beovu, an anti-VEGF treatment for wet AMD.