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.