Camurus (CAMX) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Oczyesa to treat patients with acromegaly, a disease stemming from the pituitary gland.
CHMP's positive opinion is backed by seven clinical trials of the potential drug, which showcased a "higher proportion" of patients who responded to treatment with somatostatin analogues, achieving normalized insulin growth-factor-1 levels versus placebo groups, the company said.
One of the studies also showed improvement in symptoms and quality of life, according to a statement.
The company said a final decision on the market authorization is expected from the European Commission mid-year.