FDA
19th May 2014

Roll Call Spotlight – Peripheral and Central Nervous System Drugs Advisory Committee

The Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) reviews and evaluates data concerning the safety.

Roll Call Spotlight – Peripheral and Central Nervous System Drugs Advisory Committee

The Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of various neurologic diseases. The PCNSDAC consists of a core 11 voting members, including the chair. Members are selected among authorities who are knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, and epidemiology or statistics. The committee currently has five vacancies.

This committee has not met in 2014 but convened three times in 2013. The most recent meeting, taking place last November, was held to discuss the supplemental biologics license application (sBLA) 103948-5139, alemtuzumab injection, trade name LEMTRADA (Genzyme). Although alemtuzumab injection is already approved in the U.S. for other indications, this time it was proposed for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

Lemtrada’s new indication was ultimately rejected by the FDA after the PCNSDAC failed to reach a consensus in this meeting.  The decision to reject Lemtrada came down to a disagreement over how it’s clinical trials were conducted. Specifically, the point of contention is over whether or not the more than 1,400 trial patients should have been told whether they were receiving Lemtrada or the drug it was being compared to. The FDA generally prefers trials to be blinded, and Genzyme contends that blinding would have been futile, as the methods of administration and side effects are very different for Lemtrada and its comparator drug. Interestingly, regulators in Canada, Europe and Australia deemed the trial sufficient to approve Lemtrada for this indication.

Also in November, the committee discussed new drug application (NDA) 205677, tasimelteon capsules; proposed trade name Hetlioz, (Vanda Pharmaceuticals, Inc.), for the treatment of Non-24 hour sleep-wake disorder in blind individuals without light perception. The FDA has since followed the committee’s favorable recommendation and approved Hetlioz.

In an earlier 2013 meeting, the PCNSDAC met to discuss new drug application (NDA) 204569, for suvorexant tablets (Merck Sharp and Dohme Corp), for insomnia characterized by difficulties with sleep onset and/or maintenance. The committee voted 13 to 3 in favor of approving suvorexant tablets. However, the committee recommended lower dosages than were proposed in the application due to concerns about potential next-day drowsiness in some patients. The FDA took into account the committee’s concerns about dosage, and has yet to approve suvorexant tablets. The FDA concluded that the safety data did not support the approval of suvorexant at the doses originally submitted for approval and is requiring manufacturing studies to support the lower dosage form.  If approved, assignment of controlled status by the Drug Enforcement Agency (DEA) may further prolong the final launch date.

As exemplified in these three meetings last year, the PCNSDAC carefully review the data presented to them and their outcomes are often reflected in the FDA’s decision making process. The nature of the types of drugs reviewed by this committee may impact the level of scrutiny imparted as these drugs commonly treat serious conditions or carry serious side effects. Don’t leave your next meeting with the PCNSDAC to chance – ISS’s advisory committee meeting services can help you be prepared!

White Oak Gude

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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