FDA Action Alert: Alvotech and Minerva

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Pictured: A sign at FDA headquarters/Grandbrothers/Adobe Stock

As the last full month of winter 2024 nears an end, the FDA has two target action dates: one for a Humira biosimilar and another for a schizophrenia treatment. 

Read below for more.

Alvotech Expects Decision on Humira Biosimilar

Alvotech is developing a high-concentration biosimilar to AbbVie’s blockbuster arthritis therapy Humira. The FDA is set to release its decision by Feb. 24.

Like its branded reference product, Humira’s copycat AVT02 is a monoclonal antibody that works by targeting and binding to tumor necrosis factor-α, which in turn blocks signaling cascades that would otherwise promote an inflammatory response. This mechanism of action allows AVT02 to target the underlying disease pathways of Humira’s indications, including Crohn’s disease and rheumatoid arthritis.

The FDA has already turned down AVT02 twice for manufacturing deficiencies at its facility in Reykjavik, Iceland. Alvotech’s first BLA for the candidate was rejected in April 2023, followed by a second Complete Response Letter two months later, in June 2023, specifically for its application for interchangeability.

In September 2023, Alvotech resubmitted the BLA for AVT02, seeking an interchangeability designation for its biosimilar. At the time, CEO Robert Wessman said in an investor call that the company was working to address the FDA’s comments and was “confident that the changes we have made at our site” would “put the company in the best positions for our satisfactory reinspection.”

A few weeks later, the FDA accepted Alvotech’s resubmission, indicating that it was a “complete response” to the regulator’s concerns in its previous rejections.

If AVT02 wins the FDA’s interchangeability designation, it would allow pharmacies to dispense the biosimilar in place of Humira without needing a change in prescription.

Minerva Awaits Verdict for Schizophrenia Drug

On or before Feb. 26, the FDA will decide on Minerva Neurosciences’ New Drug Application (NDA) for its investigational drug roluperidone for the treatment of negative symptoms in schizophrenia.

According to Minerva’s website, roluperidone blocks serotonin, sigma and α-adrenergic receptors, all of which play a role in the regulation of anxiety, sleep, cognition and mood. Roluperidone targets a specific subtype of the serotonin receptor called 5-HT2A without directly blocking dopaminergic receptors, allowing it to avoid the typical side effects associated with first- and second-generation antipsychotic medications.

This mechanism of action positions roluperidone as a potential answer to the negative symptoms of schizophrenia, which include lack of motivation and social withdrawal.

In October 2022, the FDA slapped Minerva with a Refuse to File letter for roluperidone, for which the company requested a Type A meeting with the regulator. In December 2022, however, despite the meeting, the FDA affirmed that the Refuse to File letter would remain in place.

Minerva again challenged the regulator’s decision in a Type C meeting in April 2022, which led to the FDA granting its appeal and ultimately accepting the application in May 2023. The FDA will consider the issues raised in its Refuse to File letter during its review of roluperidone’s NDA.

If approved, roluperidone could be an “important new option” for the unmet needs of schizophrenia patients whose negative symptoms “are a major source of disability,” Remy Luthringer, CEO of Minerva, said in a statement alongside its announcement of the target action date.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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