EMA re-confirms drug suspensions due to faulty trial data from GVK Biosciences

24-May-2015 - Last updated on 22-May-2015 at 18:42 GMT

Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences in Hyderabad, India.

EMA’s Committee for Medicinal Products for Human Use (CHMP) originally recommended in January the suspension of about 700 drugs following an inspection of GVK’s site by the French medicines agency (ANSM). The inspection raised concerns about how GVK Biosciences conducted studies after revealing data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines over the course of at least five years.

“Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated,” the EMA said in its latest report.

During the re-examination, the CHMP concluded that “concerns about the reliability of the clinical studies remain” so the agency has maintained its recommendation from earlier to suspend the medicines for which no supporting data from other studies were available, which includes about 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site.

GVK spokeswoman Dorothy Paul told Outsourcing-Pharma.com: “We have presented data from international experts regarding ECGs and they had no correlation to the studies outcome. GVK BIO has been independently working with the EU authorities and the Government of India and will continue to do so to try and resolve the issue.”

The EMA did identify one medicine in the re-examination for which concerns about studies were addressed, and that medicine -- Bivolet (nebivolol) 5 mg tablets -- is now no longer recommended for suspension.

The CHMP also noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market in some countries if they are of critical importance for patients and alternatives cannot meet patients’ needs, but that decision lies with the national authorities of EU Member States. For medicines that are considered critical, companies are given 12 months to submit additional data to the EMA.

The CHMP’s recommendation will now be sent to the European Commission for a legally binding decision. This decision will apply to all Member States regardless of whether or not they have taken interim measures to suspend medicines.