Vanda sues FDA yet again, accuses federal agency of delaying post-CRL hearing
Vanda Pharmaceuticals has filed yet another lawsuit against the FDA — and once again related to the drug it’s hoping to expand into jet lag disorder.
The serial plaintiff accused the agency of failing to give Vanda a hearing to determine if it can add a jet lag disorder indication to Hetlioz, Vanda’s FDA-approved drug to treat Non-24, a circadian rhythm disorder in which a patient’s internal clock is mismatched to the 24-hour day/night cycle.
The complaint, filed in the US District Court for the District of Columbia on Tuesday, says that the Federal Food, Drug and Cosmetic Act (FDCA) requires the FDA to publish in the Federal Register, “notice of an opportunity for a hearing” on a company’s sNDA within 180 days of the company filing, and another duty or obligation to publish the same notice within 60 days of an opportunity for a hearing.
Vanda says that it has been 1,366 days since it filed its sNDA, and 74 days since the company requested an opportunity for a hearing.
With those figures in mind, Vanda is petitioning the circuit court to “compel” the FDA to comply with its statutory obligation to act on Vanda’s sNDA within 180 days, “among several other claims for relief.”
The biotech has had a history of filing suit against the federal regulatory agency, and this is the third time so far in 2022. The most recent suit was filed back in May, accusing the FDA of failing to grant fast-track designation to Vanda’s potential chronic digestive disorder drug tradipitant, a neurokinin-1 receptor antagonist.
In terms of Hetlioz, Vanda sued the FDA in April over the drug — alleging that the agency was wrongfully withholding parts of a rejection letter for a new indication for Hetlioz (tasimelteon) for jet lag.
The company received a CRL for its sNDA for Hetlioz in August 2019, but the letter contained few details on what Vanda needed to correct, according to the company. And while the CRL shut down Vanda’s sNDA, it hardly surprised anyone — as analysts noted at the time that the market for it would be close to nil given Hetlioz’s high price point.
Per former Stifel analyst Derek Archila at the time,
It is unclear what the next steps are for this program from a timing/clinical perspective, but our view on JLD has been whether or not this is a commercially viable indication for VNDA to develop Hetlioz for. Given Hetlioz’s orphan pricing in Non-24, we had estimated the cost for 3 days of therapy for JLD would have been approximately ~$1,500, much higher than OTC and/or Rx sleep products which are typically used. For this reason, we did not include any value for this program in our model.
It is also worth noting that in the online federal court records database, Vanda’s submitted paperwork only had a summons to the FDA. However, per the court docket, “you must supply a summons for each defendant & two additional summonses for the U.S. Attorney & U.S. Attorney General.” While Vanda has to comply by close-of-business Thursday, the case is effectively at a standstill before it even began — unless those summons are sent out.
A Vanda spokesperson told Endpoints News via email that “Vanda is committed to holding FDA accountable to the law, and that includes demanding the FDA meet its statutory and regulatory timing requirements as fully described in our lawsuit.”