FDA Action Alert: Vanda, Eyenovia and Viatris/Mapi

FDA Action Alert_Taylor Tieden for BioSpace

Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace 

March is shaping up to be a busy month for the FDA, beginning with three target action dates for an insomnia therapy, an injectable multiple sclerosis medication and a topical steroid for pain and inflammation following eye surgery.

Read below for more.

Vanda Awaits Verdict on Insomnia Drug

By March 4, the FDA is scheduled to release its decision on Vanda Pharmaceuticals’ supplemental New Drug Application (sNDA) proposing its oral drug Hetlioz (tasimelteon) for the treatment of insomnia, as characterized by difficulties in initiating sleep.

Hetlioz is an orally available agonist of the melatonin MT1 and MT2 receptors, which are crucial to the control of circadian rhythms. It is currently approved for non-24-hour sleep-wake disorder. The exact mechanism of action of Hetlioz is still unknown, according to its label.

In February 2024, the FDA informed Vanda it had identified “deficiencies” in the sNDA that “preclude discussion of labeling and postmarketing requirements/commitments.”

While the FDA indicated that the communication did not reflect its final decision on the sNDA, Vanda stated in a press release that it believes that the regulator’s notice is “part of an ongoing violation of the Federal Food Drug and Cosmetic Act,” which requires the FDA to give applicants the opportunity of a hearing within 180 days of their filing.

Vanda’s sNDA was filed on May 4, 2023, which meant the FDA would have had a deadline of October 31, 2023, to provide a decision or a hearing.

Vanda is backing Hetlioz’s sNDA with data from a Phase III, placebo-controlled, four-week study, along with two transient insomnia studies.

Eyenovia Hopes to Join $1.3B Market with Ophthalmic Steroid

Also on March 4, the FDA is expected to issue a verdict on Eyenovia’s investigational APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of pain and inflammation after ocular surgery.

Initially developed by Taiwan-based Formosa Pharmaceuticals, APP13007 is a topical ophthalmic steroid. Its active ingredient is clobetasol propionate, which is a super-potent steroid that elicits rapid and sustained relief of both pain and inflammation, allowing a twice-daily dosing schedule every two weeks.

Eyenovia acquired the U.S. commercial rights to APP13007 in August 2023 for single-digit million-dollar commitments in cash and shares, payable upon the signing of the agreement, the FDA approval of the candidate, the transfer of its NDA to Eyenovia and the first commercial sale of APP13007. Formosa will also be eligible for various sales milestones for the candidate.

If approved, APPI13007 will join the $1.3 billion market of ocular steroid and steroid combinations, which sees around 7 million eye surgeries in the U.S. every year. APP13007 will complement Eyenovia’s FDA-approved mydriasis product Mydcombi and could provide the company with additional near-term revenue.

Viatris, Mapi’s MS Candidate Faces March 8 Verdict

By March 8, Viatris and Israel-based partner Mapi Pharma expect a decision on the NDA for their investigational version of glatiramer acetate GA Depot for relapsing forms of multiple sclerosis (MS).

Glatiramer acetate, sold by Teva under the brand name Copaxone, is an immunomodulating therapy that works by tempering the inflammatory response, an underlying pathologic driver of MS. The drug cannot cross the blood-brain barrier, and its exact mechanism of action is still unknown, but it is believed to enhance peripheral helper T cells and help them move into the brain to dampen inflammation in the central nervous system.

Viatris’ and Mapi’s GA Depot is a long-acting formulation of glatiramer acetate designed to be administered through an intramuscular injection every four weeks.

The partners are backing their application with data from a double-blinded, placebo-controlled Phase III trial that enrolled 1,016 patients who were given either 40 mg of GA Depot or placebo for a total of 13 doses. Study results showed that GA Depot could significantly reduce annualized relapse rate by 30.1% while also decreasing injection site reactions.

If approved, Viatris believes GA Depot could “improve patient experience through fewer injections, greater tolerability and increased compliance,” Rajiv Malik, the company’s president, said in a statement alongside the NDA’s acceptance.

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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