NEW YORK (AP) -- Santarus Inc. said Monday the Food and Drug Administration did not accept a marketing application for its drug Rhucin, which is designed to treat a genetic disorder that can cause dangerous swelling of the throat and extremities.
The FDA's decision could delay approval of Rhucin for more than a year. The agency wants data from an ongoing late-stage clinical trial, according to Santarus and its partner Pharming Group NV. Pharming started that trial earlier this month, and the company expects it to last a year to 18 months. After the FDA accepts a marketing application for a drug, it generally takes six to 10 months to review it.
Rhucin is a treatment for acute attacks of hereditary angioedema, or HAE. The companies say the FDA did not accept the marketing application because the previous clinical studies did not provide data on enough patients to support the proposed dose. The agency also said the studies did not have validation of a visual scale used to measure the drug's effects on the symptoms of HAE.
The companies said they will meet with the FDA to discuss its decision. The agency also plans to give other feedback on the design of the late-stage study, which is expected to involve about 50 patients. Santarus and Pharming say Rhucin has been tested on 190 patients in nine clinical trials.
Rhucin was developed by Pharming, and the drug was approved in Europe in November under the name Ruconest. Santarus, which is based in San Diego, holds the rights to the drug in North America. Pharming, which is based in the Netherlands, filed for FDA approval of Rhucin in late December.
Shares of Santarus fell 25 cents, or 7.7 percent, to $3 in morning trading. The stock has traded between $2.09 and $5.67 in the last year.
The FDA's decision could delay approval of Rhucin for more than a year. The agency wants data from an ongoing late-stage clinical trial, according to Santarus and its partner Pharming Group NV. Pharming started that trial earlier this month, and the company expects it to last a year to 18 months. After the FDA accepts a marketing application for a drug, it generally takes six to 10 months to review it.
Rhucin is a treatment for acute attacks of hereditary angioedema, or HAE. The companies say the FDA did not accept the marketing application because the previous clinical studies did not provide data on enough patients to support the proposed dose. The agency also said the studies did not have validation of a visual scale used to measure the drug's effects on the symptoms of HAE.
The companies said they will meet with the FDA to discuss its decision. The agency also plans to give other feedback on the design of the late-stage study, which is expected to involve about 50 patients. Santarus and Pharming say Rhucin has been tested on 190 patients in nine clinical trials.
Rhucin was developed by Pharming, and the drug was approved in Europe in November under the name Ruconest. Santarus, which is based in San Diego, holds the rights to the drug in North America. Pharming, which is based in the Netherlands, filed for FDA approval of Rhucin in late December.
Shares of Santarus fell 25 cents, or 7.7 percent, to $3 in morning trading. The stock has traded between $2.09 and $5.67 in the last year.