Take 2: Teva refiles for approval of long-acting schizophrenia drug months after FDA rejection

Teva is taking another run at the FDA approval process. Months after the agency rejected the candidate, Teva has refiled for approval of its long-acting, subcutaneous schizophrenia treatment and talked up its prospects of launching the drug in the first half of next year.

The candidate, mdc-IRM, is a significant opportunity for Teva, with the company previously expressing hopes of claiming 10% of the market and matching the price of branded patent-protected rivals. Teva looked to have laid the groundwork for approval last year, when it posted phase 3 data and filed for FDA approval, only for the agency to issue a complete response letter in April 2022.

Now, Teva has refiled for approval of its new formulation of the decades-old medicine risperidone. CEO Kåre Schultz expects things to play out differently this time around and for mdc-IRM, which will be sold as Uzedy, to emerge as a challenger for a blockbuster market. 

“We are very optimistic about it. We did a complete quality check of all our clinical data, it looked good, and we refiled it with FDA, and hope to be able to launch this product sometime during the first half of next year. That will also contribute to growth,” Schultz said on Teva’s quarterly results conference call with investors.

The attempt to turn risperidone into challenger to Johnson & Johnson’s long-acting schizophrenia drugs rests on technology from MedinCell, Teva’s France-based partner on the project. MedinCell uses its BEPO technology to formulate active ingredients so they create a depot upon administration. As the depot breaks up, the drug is slowly released to provide long-acting effects. 

MedinCell is eligible for development and commercial milestones of up to $122 million, plus royalties on net sales. Teva recently started a phase 3 trial of a second candidate based on the same technology.