Drugs

Withdraw Wakix Approval: Scorpion Capital Petition

A 4/3 Scorpion Capital LLC petition calls on FDA to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

The Scorpion Web site says the firm “specializes in intensive, differentiated research which uncovers what investors have missed and Wall Street is paid to ignore. Our investigations seek to ‘crack the case’ through a persistent and thorough process for which other market participants may lack the bandwidth or inclination. We aim to publish the most rigorous due diligence conducted to date on each fraud or promote that we target.”

The petition says Scorpion founder and chief investment officer Kir Kahlon conducted a four-month investigation into the drug’s safety and effectiveness and determined that Wakix “poses a grave danger to patients, as evidenced by the inherent and well-documented toxicity of histamine H3 receptor antagonist/inverse agonists as a drug class and by that of pitolisant specifically given its molecular structure, as well as by serious and fatal adverse events that petitioner has identified through a variety of methods….”

The petition specifically asks that FDA:

withdraw approval of Wakix for all current and future indications;
require Harmony Biosciences to distribute an immediate Important Drug Warning Letter to make healthcare providers aware of the adverse events identified in the petition; and
transition Wakix to a compassionate use program in conjunction with a REMS for current patients who stay on the drug.

The petition says it may be helpful for FDA to convene an advisory committee to discuss the issues raised in the Scorpion research report and the actions requested in the petition.

“In the NDA approval letter,” the petition says, “the agency stated that ‘Your application for Wakix was not referred to an FDA advisory committee because the application did not raise significant safety or efficacy issues that were unexpected in a drug for the intended population.’ The statement is concerning considering the known toxicity risks within the histamine antagonist class, and in particular the well-documented 40-year history of toxicity and lack of efficacy in the H3 receptor antagonist/inverse agonist class specifically.”

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