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GW Pharmaceuticals’ Epidiolex Gains Orphan Status For Treating TSC

After a rough start to 2016, GW Pharmaceuticals PLC (NASDAQ:GWPH) has been a top performing cannabis-related stock since mid-March. The company has recently secured Orphan Drug status from the U.S. Food and Drug Administration (FDA) for its experimental cannabis-based epilepsy drug.

TSC and Epilepsy

The company notified its investors through a press release that its lead cannabinoid product candidate, Epidiolex, has been given orphan status for the treatment of tuberous sclerosis complex (TSC), a rare genetic disease. The most common presenting symptom of TSC is epilepsy, which presents in 80% to 90% of all individuals with the genetic disorder, usually beginning in childhood.

Now the FDA approval has set the stage for the company to test the efficacy of Epidiolex against the TSC indication within its clinical development program. The FDA’s Orphan status is granted to those drugs that are developed to treat unmet or rare diseases affecting less than 200,000 people annually. The Orphan Drug designation offers significant incentives to the developer of drugs such as a sever-year marketing exclusivity in the United States.

Epidiolex a Cannabis Drug Candidate Standout

The potential for Epidiolex is strong based on Tuberous Sclerosis Alliance data showing nearly 50,000 people in the United States are affected by TSC. Globally, the number exceeds one million patients.

The latest orphan designation joins prior ones from the FDA for Epidiolex for the treatment of Dravet syndrome and Lenno-Gastaut syndrome. The FDA has also granted Fast Track status to Epidiolex for Dravet syndrome. Currently GW is running four Phase 3 pivotal trials of Epidiolex for Dravet and Lennox-Gastaut syndromes, two deadly forms of childhood epilepsy. Earlier this months another Phase 3 trial began evaluating Epidiolex as an add-on treatment of TSC-associated seizures.

Broadly, GW Pharma is optimistic that the drug will prove the therapeutic benefits of cannabinoids as a viable option to treat epileptic conditions where today’s medicines fail to provide meaningful or durable results.

Apart from this, the company disclosed in March that its drug has successfully treated Dravet syndrome among children in a Phase 3 study. Following the announcement, the company informed that it aims to meet the FDA in connection with seeking regulatory approval for the treatment of Dravet syndrome.

Since hitting $35.83 on March 10, shares of GWPH bolted as high at $91.65 on March 14 (news of the Phase 3 trial hitting its primary endpoint) and are currently holding around $84.

 

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