Regulatory Vanda Sues FDA Over Delay of Post-CRL Hearing

Vanda Sues FDA Over Delay of Post-CRL Hearing


Vanda Pharmaceuticals has filed a lawsuit against the FDA concerning Hetlioz, the drug it hopes to use to treat jet lag disorders. The plaintiff accused the Food and Drug Administration of failing to provide Vanda its due hearing to decide if it’s feasible to include a jet lag disorder indication to Hetlioz. 

Hetlioz is an FDA-approved medicine that treats Non-24, a sleep-wake disorder characterized by patients having sleep patterns out of sync with day and night. People suffering from this condition have trouble matching their internal clocks with the 24-hour day/night cycle. Hetlioz has been prescribed to treat this condition for the past eight years, first gaining approval in 2014.

The complaint was filed on Tuesday in the US District Court for the District of Columbia. According to the complaint, the Federal Food, Drug and Cosmetic Act (FDCA) mandates that the FDA publish a “notice of an opportunity for a hearing” on an organization’s sNDA before 180 days have passed since the filing. Additionally, the same notice must be published within 60 days of the hearing opportunity.

According to Vanda, 1,366 days have passed since it filed its supplemental new drug application (sNDA), which is nearly 1,200 days more than the typical stipulated period. Moreover, 74 days have elapsed since the company asked for an opportunity for a hearing. Taking these figures into account, Vanda is urging the court to request the FDA to follow its statutory obligation and take a stand for Vanda’s sNDA.

Interestingly, this isn’t the first time the biotech firm has sued the FDA; in fact, it’s the third time this has happened in 2022 alone. Back in May, Vanda accused the FDA of failing to grant fast-track status to tradipitant, its potentially chronic digestive disorder drug.

Vanda had also sued the FDA over Hetlioz in April. The company claimed the FDA was wrongfully concealing some parts of its rejection letter and refusing to disclose the reason behind the disapproval of Hetlioz as a treatment for jet lag.

Vanda received a complete response letter (CRL) from the FDA for Hetlioz in 2019. However, the letter didn’t give away much in terms of what Vanda needed to correct, according to the company. Ultimately, the CRL shut down the sNDA, but it didn’t come as too much of a surprise to anyone; many analysts noted that due to Hetlioz’s sky-high price point, it wouldn’t be able to penetrate the market at that time.

Derek Archila, Stifel’s analyst at the time, noted, “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.”

Presently, Vanda remains committed to ensuring that the FDA is accountable to the law and meets its obligations as mentioned in the lawsuit.

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