Briefs: BioMarin files Vimizim in Brazil; Kyowa Hakko submits KRN125 in Japan; Insmed's Arikace update

USA-based BioMarin Pharmaceutical (Nasdaq: BMRN) has submitted the Vimizim (BMN-110, elosulfase alfa) Marketing Application (MA) to the ANVISA, the National Health Surveillance Agency Brazil. Assuming priority review status, based on orphan drug status in the USA and European Union, an approval decision from ANVISA is anticipated in mid 2014, the company said.

"Considering that Brazil, along with the USA, are expected to be the largest market opportunities for Vimizim, the timely submission in this market is an important milestone in our efforts to bring the first therapeutic option to patients with Morquio A Syndrome," said Jean-Jacques Bienaime, chief executive of BioMarin. "Along with orphan drug designation in the USA and EU, priority review status in the US and accelerated assessment status in the EU, we are making good progress on a global basis. In the coming months, we will continue to work closely with regulatory authorities and prepare for the launch of Vimizim worldwide," he added.

Kyowa Hakko Kirin submits KRN125 for Approval in Japan