Japanese approvals for Eylea, Tresiba, Seebri and Aimix

There was a flurry of announcements from Japan’s Ministry of Health, Labor and Welfare (MHLW) on Friday, the first of which was good news for German drug major Bayer (BAYN: DE) and US partner Regeneron (Nasdaq: REGN), with the news that the regulator has approved the companies’ Eylea (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).

The MHLW approval of EYLEA is based upon the results of two Phase III clinical studies (VIEW 1 and VIEW 2) which demonstrated that Eylea dosed every other month, following three initial monthly doses was clinically equivalent to Lucentis (ranibizumab injection) dosed every four weeks, as measured by the proportion of patients who maintained visual acuity (less than 15 letters of vision lost on an eye chart) over 52 weeks, the primary endpoint of both studies. The most common adverse reactions (5.0% or more) reported in patients receiving Eylea were conjunctival hemorrhage, eye pain, vitreous detachment, cataract, vitreous floaters, and increased intraocular pressure.

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