FDA will decide in the month of August this year whether to approve zuranolone, a medication developed by Biogen and Sage Therapeutics and also decide to accept it for priority review as a therapy for major depressive disorder (MDD) and postpartum depression (PPD).
Biogen and Sage started the filing process for zuranolone in MDD. The parties then intended to file a related document in PPD during the first half of 2023. Final filings for both indications were completed by the team late last year. They were rewarded with an FDA decision date that maintains their aspirations for a 2023 second-half launch for zuranolone.
The FDA accepted the new application for zuranolone and gave it priority evaluation for two indications related to mental health, according to a statement from Cambridge biotech and its partner Sage Therapeutics. The neuroactive steroid created by Sage is intended to be used episodically. If authorised, zuranolone would be the first depression medication available in the market with a treatment cycle of 14 days.
The FDA’s approval of the application is the most recent victory in Sage’s effort to bounce back from the disappointment of the phase 3 trial study of zuranolone in MDD that was unsuccessful in 2019. When Biogen joined the team in 2020, the two of them worked together to complete a three-point R&D effort that was initially planned to bring the molecule to market in 2022. The partners did not reach their goal but the positive side is that they can now identify their finish line.
The MD of Biogen Priya Singhal released a statement:
“We see the potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD. The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression.”
Biogen and Sage are requesting FDA approval on several studies, namely their five MDD studies, two PPD trials, a mid-phase MDD study that Shionogi conducted in Japan, and five investigations in MDD. According to the developers, the findings put the medication candidate in a positive spot to revolutionize the way that PPD, partial responders, patients with anxiety, and adherence challenges are treated for MDD. Around the middle of the year, Sage intends to disclose further data from one of the MDD studies, SHORELINE, as well as additional analysis of the outcomes from all the trials throughout 2023. The assessments will cover patient-reported outcomes, health economics, and other elements that may be crucial as the partners work to convince payers to cover the medicine.
The company believes that there is potential for the medication in the market. According to a study conducted by Global Load of Disease, mental health issues are one of the major global sources of disability and disease burden. PPD, which affects around one in eight postpartum women, is one of the most frequent medical issues during and after pregnancy.
A survey conducted in 2020 showed that there are 190 million cases of major depressive disorder globally, including 14 million cases in the United States. One of the reasons for this high number has been found by experts to be the Covid-19 pandemic.