The FDA accepted Zuranolone's NDA application and granted it priority review rights for the treatment of MDD and PDD

On February 2023, 2, Biogen ("Biogen") and Sage Therapeutics ("Sage") jointly announced that the FDA has accepted a New Drug Application (NDA) for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). The application has been prioritized for review, and the FDA has designated an August 6, 2023, action date for the Prescription Drug User Fees Act (PDUFA).

About Zuranolone

Zuranolone is a two-week, once-daily oral drug that is a neuroactive steroid (NAS) GABA-A receptor-positive allosteric modulator (PAM). The GABA system is the main inhibitory signaling pathway in the brain and central nervous system that helps regulate brain function. Zuranolone, an improvement on the first drug for the treatment of postpartum depression, has optimized the selectivity for synaptic and extrasynaptic GABA receptors and the pharmacokinetic profile of oral administration, overcoming the major drawback of brexanolone's need for intravenous administration for 60 hours, with the potential advantage of "first in class".

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In 2020, Biogen entered into a strategic partnership with Sage with a down payment of 8 million, equity of 75 million, mileage of 6.5 billion plus sales commissions, mainly around the development of zuranolone.

Zuranolone's NDA is based on positive data from two R&D projects, LANDSCAPE and NEST. THE LANDSCAPE INCLUDED FIVE STUDIES (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, AND CORAL STUDIES) IN ADULTS WITH MDD, AND NEST INCLUDED TWO STUDIES (ROBIN AND SKYLARK STUDIES) IN WOMEN WITH PDD.

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In February 2022, the COLAL study of zuranolone in patients with MDD reached its primary endpoint and showed rapid efficacy against depressant symptoms, with a more pronounced effect than placebo observed on day 2 of the 2-week course.

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In June 2022, the SKYLARK study of zuranolone in patients with PPD showed statistically significant and clinically significant improvements in depressive symptoms on day 6 (primary endpoint) and days 15, 3, and 28 (key secondary endpoint), namely: the minimum squares (LS) mean (SE) CFB of -45.50 (15.17) in the total HAMD-15 score on day 6 in women receiving zuranolone 0 mg, Compared with -82.11 for women receiving placebo (LS mean difference -6.4 points; p=0.0) (primary endpoint). In addition, patients treated with zuranolone 0007 mg had a statistically significant improvement in clinical global impression severity (CGI-S) compared to baseline at day 50 compared to placebo (zuranolone -15.2vs. placebo-2.1, p = 6.0).

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About MDD and PDD

Depression is an emotional disorder characterized by depressed mood, the cause of which has not yet been clear, and it is generally believed that many factors such as biological, psychological and social environment cause it. MDD is characterized by at least two weeks of generalized low mood, low self-esteem, and loss of interest or pleasure in enjoyable activities.

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Symptoms of PPD, which include low mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, poor concentration, and in some cases suicidal thoughts, are among the most common complications during and after pregnancy.

According to data from the World Health Organization (WHO), more than 3 million people worldwide suffer from varying degrees of depression, and depression will rank first in the global burden of disease by 5, and the increase in depression patients will drive the demand for depression drugs.

Number of people with depression in different parts of the world, 1990-2019

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According to Frost & Sullivan, the number of depressed patients in China reached 2018 million in 6200, and it is expected to reach 2.6 million in 2023 with an annual growth rate of 7050.2017%. With the rapid development of China's antidepressant drug market, the sample hospital market size reached 100.3 billion yuan in 2022, and according to Sullivan, it will reach 184.1 billion yuan in <>.

The main antidepressant medication