Second time's a charm for Teva Pharmaceuticals and MedinCell, as the partners jointly announced that the U.S. FDA has approved Uzedy, an extended-release injectable suspension for the treatment of schizophrenia in adults.
The U.S regulator had rejected the drug last April. Neither company revealed the reason behind the complete response letter, other than to say Teva worked to "conduct a complete quality check of all clinical data." Teva then re-submitted the New Drug Application to the FDA in November.
Uzedy is the first product that utilizes Paris-based MedinCell’s proprietary BEPO technology (licensed to Teva under the name SteadyTeq), a copolymer technology that controls the steady release of risperidone.
"Given Uzedy's differentiating features and positive phase 3 results, we believe it has the potential to establish a new standard of care for patients with schizophrenia," said Christophe Douat, CEO of MedinCell.
Current treatments for schizophrenia are typically prescribed as daily oral medications, which can lead to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia.
The approval is based on data from two phase 3 trials evaluating Uzedy in patients with schizophrenia: TV46000-CNS-30072 (the RISE study) and TV46000-CNS-30078.
Per the long-standing agreement with Teva, MedinCell is entitled to receive royalties on all sales and is eligible for up to $105 million in commercial milestones.
The new treatment will be available in the U.S. in the coming weeks.