Shares of United Therapeutics Corp. climbed nearly 18 percent yesterday after the company said the Food and Drug Administration had issued a letter describing the company's drug Remodulin as "approvable."
The Silver Spring company's stock rose $1.66 to close at $11.10 on the Nasdaq stock market. More than 3.1 million shares traded hands, nearly 12 times the daily average volume of 265,967 shares over the last six months.
The FDA stopped short of approving Remodulin, a treatment for pulmonary hypertension, which would be United Therapeutics' first drug on the market.
An "approvable" letter is no guarantee that the drug will make it to market. But it generally indicates that approval will be forthcoming if the company can address any outstanding questions the FDA has identified.
"If they can't answer them and don't provide the data, it can become a non-approval," FDA spokeswoman Laura Bradbard said, speaking generally. Bradbard said she was unfamiliar with both United Therapeutics and its drug.
The company, however, said the agency intends to approve Remodulin but with a requirement that United Therapeutics must conduct a final clinical trial to verify the drug's benefit. That trial would be conducted after Remodulin is on the market.
The company and the agency also are negotiating over what the drug's label will say.
"We will work diligently with the FDA to satisfy the remaining requirements for approval of Remodulin so that pulmonary arterial hypertension patients will have access to this therapy as quickly as possible," said Roger Jeffs, United Therapeutics' president and chief operating officer.
Up to 50,000 people in North America and Europe have pulmonary arterial hypertension, a potentially fatal disease characterized by high blood pressure in the vessels between the heart and lungs. Symptoms include extreme fatigue and shortness of breath. Often, patients are too exhausted to do simple chores or climb steps.
United Therapeutics has argued that Remodulin is superior to GlaxoSmithKline's Flolan, which has been the standard treatment for pulmonary hypertension patients. Flolan is administered via a catheter to the chest. Remodulin is pumped from a cassette into a needle under the skin. The difference, United Therapeutics has argued, reduces the chances for infection and improves patients' quality of life.