23 Nov 17

BioMarin Pharmaceutical announces FDA acceptance for Kuvan BioMarin Pharmaceutical Inc. Provides announced that the U which to choose .S. Food and Medication Administration offers granted marketing authorization for Kuvan Tablets, the 1st specific medication therapy accepted for the treating phenylketonuria . Tomorrow Shipments to the distribution channel will commence, and BioMarin will immediately start promotion of Kuvan. The authorization of Kuvan represents a significant milestone for PKU sufferers and their families and in addition for BioMarin. We are really pleased to provide this promising treatment substitute for market in just just a little over three years because the IND filing, and we are actually ready for an instantaneous launch, said Jean-Jacques Bienaime, CEO of BioMarin.


This 450-individual trial aims to look for the short-term and the long-term cognitive advantage and anti-psychotic efficacy, protection and tolerability of BL-1020 in schizophrenia individuals, weighed against Risperidone as the positive control. The CLARITY trial is proceeding according to schedule at sites in India and Romania. Dr. Kinneret Savitsky, CEO of BioLineRx, mentioned, We are really pleased at receiving acceptance for the European Patent covering BL-1020 which joins the broad safety we’ve already received in various other territories, securing a wide basis for our potential commercial operations. We believe this represents significant additional improvement in the commercialization and advancement of BL-1020.