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Thursday, the FDA declined to approve Vanda Pharmaceuticals Inc.’s New Drug Application (NDA) of tradipitant for symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).
Gastroparesis (means paralysis of the stomach) is a condition that slows down the stomach’s ability to empty its contents.
It is associated with severe nausea, vomiting, and difficulty finishing a normal meal.
Also Read: What’s Going On With Vanda Pharmaceuticals Shares Today?
The FDA has approved no effective treatment in over 40 years.
Vanda’s tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer-reviewed journals.
The CRL was conclusory in nature. It generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder.
Furthermore, the FDA’s action was delayed by more than 185 days and failed to satisfy the Food Drug and Cosmetic Act (FDCA) requirements.
The FDCA requires that the FDA review a new drug application and provide either an approval or an opportunity for a hearing within 180 days of submission. In this case, the FDA failed to do either.
Despite the FDA’s disappointing action, Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard and has a favorable benefit-risk profile for gastroparesis patients.
While Vanda has repeatedly requested that the FDA convene an expert advisory committee to review the application and advise the Commissioner on its approvability, the FDA has refused to do so.
The company added that several patients currently treated with tradipitant have filed a Citizen Petition urging the FDA to approve tradipitant for gastroparesis.
Vanda will continue to pursue the marketing authorization for tradipitant and support the expanded access program.
Vanda plans to submit a separate NDA for tradipitant to prevent vomiting in motion sickness later this year.
Price Action: VNDA stock is down 7.68% at $4.57 at the last check on Thursday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
** Shares of drugmaker Vanda Pharmaceuticals VNDA.O fall 10.9% to $4.41 premarket
** Co says U.S. FDA declined to approve its stomach paralysis drug, tradipitant
** Co says the FDA suggested that Vanda conduct additional studies
** Will continue to pursue approval for the drug to treat gastroparesis, characterized by delayed gastric emptying
** Plans to submit separate marketing application for tradipitant to prevent vomiting during motion sickness later this year
** Stock up 17.3% YTD vs 11.3% rise in the Nasdaq Biotechnology Index .NBI
(Reporting by Sneha S K)
(( Sneha.SK@thomsonreuters.com ;))
By Colin Kellaher
The Food and Drug Administration has turned away a proposed drug from Vanda Pharmaceuticals to treat the stomach disorder gastroparesis.
Vanda on Thursday said the FDA has issued a so-called complete response letter for the drug, tradipitant, indicating the agency won't approve the application in its current form, and called for additional studies.
The Washington biopharmaceutical company said it believes the FDA "generally disregarded" evidence from two placebo-controlled trials, and that the additional studies the agency suggested include "a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder."
Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate application later this year seeking a green light for the drug for the prevention of vomiting in motion sickness.
Write to Colin Kellaher at colin.kellaher@wsj.com
Adds details from company statement in paragraph 6 and 7, analyst comment in paragraph 9, background throughout
Sept 19 (Reuters) - Vanda Pharmaceuticals VNDA.O said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.
Shares of the company fell about 14% to $4.26 in premarket trading.
Vanda was seeking the health regulator's nod for the drug, tradipitant, to treat symptoms of gastroparesis, a condition characterized by delayed gastric emptying.
The disease is associated with symptoms such as severe nausea, vomiting, and difficulty finishing a normal meal.
The decision comes as another setback for Vanda after the FDA declined to expand the approval of its drug Hetlioz to treat insomnia earlier this year.
In response to FDA's rejection, the company said the additional studies required by the FDA had a design that was "inconsistent with the advice of key experts in the field", adding that it will continue to pursue the drug's approval.
Vanda has repeatedly requested the FDA to convene a panel meeting of experts to review the drug, but the regulator has refused to do so, it said.
Tradipitant, which Vanda licensed from Eli Lilly LLY.N, failed to meet the main goal of change in the severity of nausea, compared to placebo, at 12 weeks in a late-stage trial.
Vanda still needs to meet the FDA's request for additional animal studies and long-term safety data, raising the question if the drug can be prescribed for chronic use, Jefferies analyst Andrew Tsai said.
The FDA had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks due to safety concerns.
It is also studying the drug to prevent vomiting during motion sickness and plans to submit a separate application for it later this year.
(Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan and Leroy Leo)
(( Sriparna.Roy@thomsonreuters.com ))
Keywords: VANDA PHARMS-STOMACH PARALYSIS/ (UPDATE 2)
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