In the coming months, the European Commission (EC) is expected to make a final decision on granting marketing authorization for Cerdelga in the European Union (EU).
In August, the US Food and Drug Administration (FDA) approved Cerdelga and is currently under review by other regulatory authorities worldwide.
Genzyme president and CEO David Meeker said: "Today’s CHMP opinion is the next step in ensuring that Cerdelga is available to eligible adults with Gaucher disease type 1 living in the European Union.
"The standard of care for Gaucher disease is Cerezyme (imiglucerase for injection). With the availability of an effective oral therapy, Cerdelga would offer some patients and their physicians more choice in how to manage this serious disease."
The positive opinion was based on data from the Cerdelga clinical development program, which involved around 400 patients with Gaucher disease treated in 29 countries.
According to the company, the most common adverse reactions are fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.