EMA Recommends Suspending Alkem Drug Over Flawed Studies

Regulatory News

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India.

In light of the issues, EMA says that studies conducted by Alkem at the facility between March 2013 and March 2015 cannot be relied on to support marketing authorizations.

The recommendations stem from a review EMA launched in April after German and Dutch regulators found evidence of data manipulation in two trials done at the facility during a joint inspection in March 2015.

"The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015," EMA says, though the agency notes there is "no evidence of harm or lack of effectiveness linked" to the company's misconduct.

However, the issues at Alkem's Taloja facility appear to have been addressed since the initial inspection. In March 2016, the UK's Medicines and Health care Products Regulatory Agency conducted a follow-up inspection of the facility, and while the agency initially cited the company for eight observations, Alkem announced earlier this month that it had closed out the inspection after resolving the issues.

Review and Implications

Based on its findings, EMA's Committee for Medicinal Products for Human Use (CHMP) is recommending the suspension of Alkem's marketing authorization for its generic version of Rilutek (riluzole), and says that other studies conducted at Alkem's Taloja facility cannot be used to support marketing authorization.

Despite the suspension, EMA says it does not expect the suspension of Alkem's version of riluzole to have an effect on EU patients, as the company has not begun marketing the drug in the EU and because other versions are available.

During the review, EMA also looked into pending and approved marketing authorization applications for two other drugs that relied on studies conducted by Alkem.

Only one other drug was impacted by the review, an ibuprofen generic manufactured by Finish drugmaker Orion. According to EMA, the drug is being reviewed by national regulators and cannot be approved unless "alternative studies from other sources" are provided.

However, EMA says that acceptable studies from alternative sources have been provided for the three remaining drugs, all three of which are generic versions of the antibiotic cefuroxime. As such, EMA says that versions of the drug currently marketed by Alkem and Slovenian drugmaker Krka can remain on the market, while an application sponsored by Lithuanian drugmaker Ingen Pharma currently under reviewed can still be considered for approval.

Now, the European Commission will review EMA's findings before it issues a legally binding decision on the drugs.

EMA