This week, PIRG joined an amicus brief defending the FDA’s decision to approve a clinically superior drug to compete with a twice-nightly medication to treat narcolepsy, a condition that affects individuals’ ability to sleep. Jazz Pharmaceuticals, Inc sued the federal government saying it should not have approved competitor Avadel’s once-a-night treatment for narcolepsy, Lumryz.
The Orphan Drug Act was intended to encourage innovation.
Jazz argued that the FDA’s approval of Avadel’s version, under the Orphan Drug Act, violates the seven year exclusivity granted to Jazz for Xywav. The Orphan Drug Act encourages innovation for prescription drugs for conditions affecting small populations of patients. To incentivize drug companies to find treatments for rare conditions, the Act grants seven years of exclusivity to develop, market, and sell a drug. However, Orphan Drug exclusivity is not intended to stall or stem further innovation for that condition and allows the FDA to approve additional medications if they offer a superior clinical benefit.
Lumryz provides a superior clinical benefit.
In the amicus brief, PIRG argues that Avadel’s once-nightly treatment offers patients significantly better treatment. The original treatment offered by Jazz requires patients to wake up around midnight to take a second dose of medication. Patients reported being too drowsy to find and take their second doses, going to drastic extremes to ensure they would be awake enough to do so. Relationships with significant others, schedules in houses with newborns, and job performance also suffered.
PIRG believes the FDA’s decision to approve this newer, improved treatment for narcolepsy is not in violation of the Orphan Drug Act. In fact, it is exactly the type of innovation that should be encouraged in drug development. Jazz Pharmaceuticals had a corner on the market for narcolepsy under its 7 year exclusivity. It had little incentive to be innovative as it already had full market share of patients with narcolepsy who wanted medication. Avadel took the risk and figured out how to take this drug and make its effects last through the night – a significant innovation for someone trying to get a full night’s rest.
Patients deserve innovation.
Patients deserve a competitive market that supports true innovation. The FDA made the right choice in approving Lumryz, the single-dose medication from Avadel. Now patients have a choice and the innovator is rewarded with the ability to compete with the Jazz product. With the backing of amicus briefs like this one, the courts should side with the FDA and the patients who will benefit from clinically superior options on the market.
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