FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application

FDA Rejects Teva and MedinCell’s Schizophrenia Drug Application

April 21st, 2022 // 3:26 pm @

Teva and French biotechnology company MedinCell have intended to compete in the competitive schizophrenia drug market, but their NDA was recently rejected by FDA.

FDA sent both companies a full response letter this month. It rejected their request for drug approval for a subcutaneous version of the drug risperidone. Teva told the media it is committed to getting the new version approved and will work with the agency to address the shortcomings listed in the letter.

However, the companies did not list the deficiencies found by FA. But MedinCell stated on its website that Teva would resolve the matter.

Drug industry experts believe there could be a nine to 12 month delay in getting the risperidone drug approved. They said that simple questions or a check of drug production sites could lead to about a six month delay. But if FDA wants more clinical trials, the delay may be much longer.

Teva has sold a generic form of J&J’s Risperdal for more than a decade. But since that time, J&J has gotten a stronger foothold in the schizophrenia drug business by developing highly effective, long-acting drugs.

In September 2021, J&J received approval for Invega Hafyera, which is the only twice-yearly drug available for schizophrenia. In 2021, J&J sold $4.6 billion of Risperdal and Invega drugs.

FDA accepted the NDA from MedinCell and Teva last year after two phase 3 clinical trials showed the drug was effective for the condition.

Drug industry observers have noted it’s a good sign that the BEPO technology MedinCell uses was not questioned by the agency. Analysts are still optimistic that the new drug can be approved in the future.

They see two big advantages for this drug’s technology. First, it may reduce side effects associated with the originator drug and it also boost observance with fewer administrations. This approach could offer an ideal solution to common problems with schizophrenia treatments.

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