FDA issues CRL for AstraZeneca’s Seroquel XR, seeks drug safety plan

London, United Kingdom, December 26: Holding back on the decision to grant a marketing approval to AstraZeneca’s anti-psychotic drug Seroquel XR (quetiapine fumarate), the US Food and Drug Administration instead issued a Complete Response Letter (CRL) for the drug, seeking additional risk information, the drug maker revealed.

While Seroquel, the base formula of Seroquel XR, was approved in United States in 2007 to treat people with schizophrenia, and in October 2008 for the treatment of bipolar depression, psychiatric diagnosis for mental disorders, the drug was awaiting the FDA approval for its use in patients suffering from major depressive disorder.

The approval delay is based on over 9,000 Seroquel lawsuits filed by users, charging failure to warn about serious side effects, FDA said.

As per the requirements of the Complete Response Letter, the drug maker is to provide a strategically designed plan detailing the potential risks of the drug. Fortunately, the federal regulators have not asked for more clinical data, thus avoiding a hefty delay in its approval.

The Complete Response Letter, however, does not change the current recommendations for the treatment of patients taking Seroquel.

Although the news came around as a shock, pulling down shares by 2 percent to 2,655 pence ($39.02) on the London Stock Exchange, market analyst Savvas Neophytou said, "the safety profile of Seroquel XR is well known as it is already on the market for the treatment of schizophrenia and bipolar depression. The regulator's concerns can therefore relate only to the effectiveness of the drug."

However, the company is now practicing a completely focused approach. "It (AstraZeneca) is evaluating the contents of the Complete Response Letter and the proposed labeling revisions" the company officials proclaimed.

"At this point in time, we don't know if this means that there will or there won't be a delay or whether this could lead to no approval" an anxious AstraZeneca noted.

"AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course" officials averred.