The European Medicines Agency has affirmed its January recommendation, calling for the suspension of more than 700 products tied to improprieties at a GVK Biosciences facility in India.
The EMA's Committee for Medicinal Products for Human Use made its initial recommendation after reviewing data on more than 1,000 marketed drugs that came through GVK's site, finding about 300 with enough third-party results to support their approvals. For the rest, the agency is recommending suspension of marketing authorization until companies can replicate the questionable data, making an exception for medicines of critical importance.
At the request of some of the companies involved, CHMP conducted a re-examination of the same studies but found no reason to reverse its decision. This week, the EMA affirmed its recommendation that the products be suspended across the continent, and now the European Commission will hand down a final decision in the coming months. France, Germany, Belgium and Luxembourg have already suspended a number of GVK-related drugs.
The issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility and discovered that the CRO's workers repeatedly switched out patient ECG scores with those of healthy volunteers.
|GVK CEO Manni Kantipudi|
The ensuing fallout has made life difficult for GVK, costing the company millions in cancellations and lost contracts, CEO Manni Kantipudi has said.
Before running into trouble with European regulators, GVK had been rapidly expanding its operations throughout and beyond India. The fast-growing company has quickly transitioned from a local player into an international entity, making its way into the U.S. through a buyout of California's Aragen Bioscience earlier this year. Among the CRO's partners are Astellas, Bayer, Endo Health Solutions ($ENDP), Onconova ($ONTX) and the FDA.
- read the statement (PDF)