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The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a MAA for Alkindi to Swissmedic.
The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a marketing authorization application (MAA) for Alkindi to the Swiss regulatory body, Swissmedic.Alkindi
According to an Oct. 21, 2020 press release, the MAA has been based on the European regulatory dossier and published clinical trial data on Alkindi—hydrocortisone granules in capsules for opening. EffRx anticipates a potential market launch for Alkindi in Switzerland by 2022 and will receive the exclusive rights to market and sell the product in Switzerland once the product has been registered.
“We are pleased to see the submission of a MAA for Alkindi in Switzerland by EffRx,” said Martin Whitaker, CEO of Diurnal, in the press release. “[This] announcement is yet further validation of the quality of our products and broadens the future availability of Alkindi outside our core markets in line with our global strategy. We look forward to working with EffRx to make Alkindi available to patients suffering from pediatric adrenal insufficiency (AI) in Switzerland.”
Alkindi is already approved and marketed in Europe and is the first preparation of hydrocortisone that has been specifically designed for pediatric use in the treatment of AI and the related condition, congenital adrenal hyperplasia.