Cracked vials have led to the suspension of a clinical trial. Biotech drug developer Anthera found the cracks in vials of its experimental lupus drug, A-623, which is in Phase IIb testing.
The company announced Tuesday that it has suspended dosing and enrollment in the trial while it investigates.
Faulty vials were discovered by a clinical investigator at one of the trial sites. Upon investigation, the company found additional cracked vials in the drug storeroom of another facility. CEO Paul Truex says in a release that he's committed to resolving the issue and discussing plans with the FDA.
- see the Anthera release