Bayer’s Eylea approved in Japan
pharmafile | June 29, 2015 | News story | Sales and Marketing | Eylea, Japan, aflibercept. bayer
German firm Bayer has been shown the green light by the Japanese Ministry of Health, Labour and Welfare to market its treatment Eylea for macular oedema.
The approval decision means that Eylea (aflibercept solution for injection) is available in Japan for macular oedema secondary to retinal vein occlusion (RVO), an indication which includes macular oedema secondary to branch retinal vein occlusion (BRVO), as well as the previously-approved indication of macular oedema secondary to central retinal vein occlusion.
Retinal vein occlusion is a significant cause of vision impairment and a chronic disease that requires early and ongoing management to obtain the best possible vision.
It also means that Japan has become the latest territory, after the US and Europe, to add new indications to Bayer’s list for Eylea. The list now includes diabetic retinopathy in people with diabetic macular oedema and wet age-related macular degeneration.
Eylea is co-developed with biologics specialist firm Regeneron. The companies’ push to widen the groups of patients for which it is available has seen sales rise 55% to €253 million – the biggest sales increase of any Bayer prescription pharma product in the first quarter of 2015.
The approval is based on positive results from Phase III VIBRANT study in patients with visual impairment due to macular oedema secondary to BRVO. After six months of treatment more than half of the patients who were treated with Eylea gained at least three lines (15 letters) of vision on an eye chart.
Dr Joerg Moeller, Bayer’s head of global development says: “Especially in Japan, the retirement age tends to be rising due to declining birth rates and ageing population. The loss of even a single line of letters on an eye chart may impact a patient’s ability to work, and could mean they leave the workforce early.
“Therefore it is of utmost importance to have treatment options available which demonstrated in clinical studies rapid and significant improvements in vision for RVO patients regardless of disease severity.”
Lilian Anekwe
Related Content
Working mum develops COVID-19 vaccination database in Tokyo
A 36-year-old former English teacher living in Tokyo, Japan, has launched her own healthcare database, …
Japan approves Moderna & AstraZeneca COVID-19 vaccines
A Japanese government panel has approved Moderna and AstraZeneca’s COVID-19 vaccines for use in adults, …
Incyte biliary tract cancer treatment approved in Japan
The Japanese Ministry of Health, Labour, and Welfare (MHLW) have approved Incyte’s Pemazyre (pemigatinib) for …
