Thursday after the bell, shares of Questcor Pharmaceuticals Inc. (QCOR) gained more than 12%, after the company won an FDA expert panel vote backing the safety and efficacy of the proposed indication of H.P. Acthar Gel for the treatment of infantile spasms.
Infantile spasm, or IS, is a seizure disorder of early childhood also known as West Syndrome. The onset is predominantly in the first year of life, typically between 3 to 6 months. The typical pattern of IS is a sudden bending forward and stiffening of the body, arms, and legs; although there can also be arching of the torso.
The regulatory agency's Advisory Committee for Peripheral and Central Nervous System Drugs voted 22 to 1 in favor of H.P. Acthar Gel's efficacy as a treatment for patients with IS and voted 20 to 1 in favor of the drug's safety at an effective dosing regimen.
The FDA panel also voted 16 to 7 that the company has submitted evidence to support its view that a two-week course of treatment with H.P. Acthar Gel followed by a two-week tapering regimen provides sustained effectiveness. In addition, the Advisory committee voted 12 to 10 (with one abstention) that the company has not provided evidence that adverse effects caused by H.P. Acthar Gel are manageable and reversible.
H.P. Acthar gel is an injectable drug that is already approved in the U.S. by the FDA for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus. Pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with infantile spasms.
Two times over the past three years, the FDA had turned down Questcor's supplemental New Drug Application for H.P. Acthar Gel for the treatment of infantile spasms.
Questcor initially submitted its supplemental New Drug Application for H.P. Acthar Gel to the FDA in June 2006 and was issued a "not approvable" letter" by the regulatory agency in May 2007.
The company resubmitted its supplemental New Drug Application for H.P. Acthar Gel in December 2008 and completed its filing in March 2009. However in May 2009, the FDA requested the company to include additional statistical analysis relating to data from one secondary study.
Following the FDA's request, the company resubmitted its filing to the FDA for its supplemental New Drug Application again for H.P. Acthar Gel last October. The FDA accepted the company's supplemental New Drug Application for H.P. Acthar Gel for review late last December and decided to convene an Advisory Panel meeting to obtain independent expert advice on specific aspects of the supplemental New Drug Application.
Now that the proposed indication of H.P. Acthar Gel for infantile spasms has cleared the penultimate regulatory hurdle by winning the FDA panel backing, the next litmus test will be when the drug faces the final FDA decision. The FDA usually follows the recommendations of its expert panels though it is not mandatory. The FDA is expected to make a final decision on June 11.
Sabril is the first and the only FDA-approved drug for infantile spasms. The drug developed by Danish pharmaceutical company H.Lundbeck A/S (HLUKY.PK) was approved as recently as August 21, 2009 for that indication. The drug was launched in the U.S. last September with an extensive REMS (Risk Evaluation Mitigation Strategy) program as required by the FDA.
Trading of QCOR was halted pending the FDA panel review on Thursday. In after-hours trading, the stock was up 12.3% at $10.30.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.