Tuesday, September 17, 2013

BMN-111 phase 2 study has been authorized by the FDA

Biomarin has just announced that both the FDA and the European agency have authorized Biomarin to proceed with the phase 2 program of BMN-111 for achondroplasia:

BMN 111 for the Treatment of Achondroplasia
The company announced today that based on recent meetings with the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA) it will be able to proceed directly to a Phase 2 study of BMN 111, an analog of C-type Natriuretic Peptide (CNP), for achondroplasia. BioMarin previously completed a Phase 1 study in adult healthy volunteers. The FDA had placed a partial clinical hold on BMN 111, but at a recent meeting indicated that following submission of a modified Phase 2 protocol, and withdrawal of the previous Phase 2 study protocol, the clinical hold can be lifted and that no further data is required before initiating a Phase 2 study. The company expects to initiate its first global study in pediatric patients with achondroplasia in the fourth quarter of 2013 or the first quarter of 2014.

This is the link for the press release.

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