Bayer AG (BAYN)’s experimental lung drug won the backing of U.S. regulatory advisers to treat two forms of pulmonary hypertension.
Bayer’s riociguat should be approved for the condition that can eventually lead to fatal heart failure, a panel of advisers to the Food and Drug Administration voted 11-0 today at a meeting in Silver Spring, Maryland. The pill would be the first to treat pulmonary hypertension that lasts six months or longer often caused by a blood clot in the lungs.
Riociguat, which Leverkusen, Germany-based Bayer has proposed calling Adempas, may generate $498 million in sales by 2017, according to the average of six analysts’ estimates compiled by Bloomberg. The World Health Organization separates pulmonary hypertension, or high blood pressure in the arteries to the lungs that makes the heart work harder, into five categories.
For a patient who can’t undergo surgery “this is probably the only medical therapy that’s been shown to have a benefit,” Linda Fried, a panel member and chief of peritoneal dialysis at the Veterans Affairs Pittsburgh Healthcare System, said during the meeting.
The pill improved the distance patients can walk during a six-minute test in clinical trials and should be approved though at a lower dose than what the company sought, FDA staff said in a report last week ahead of the meeting. The panel disagreed. Bayer is seeking approval for a maximum 2.5 milligram dose.
FDA staff recommended patients with both forms of pulmonary hypertension start at a 0.5 milligram dose three times daily and increase the dose 0.5 milligram to a maximum of 1.5 milligrams three times a day. Chronic patients who don’t respond could increase the dose to 2.5 milligrams, staff said “though there is no clinical trial evidence of benefit from these higher doses and there appears to be an increased incidence of drug-induced hypotension,” or low blood pressure.
Most panel members said doctors need flexibility.
“In this field we need the opportunity to adjust the dose for the patient,” said Stuart Rich, a panel member and attending physician at the Center for Pulmonary Hypertension at the University of Chicago Hospitals. “They will let me know if their blood pressure is too low because there’s a symptom associated.”
Bayer asked the FDA to approve riociguat to treat chronic pulmonary thromboembolic hypertension. The condition affects about 5,000 people each year and now can only be treated with a complex surgery, the Cleveland Clinic says on its website. The company also applied to sell the drug to treat pulmonary arterial hypertension that is often inherited or has no known cause.
Actelion Ltd. (ATLN), based in Allschwil, Switzerland, is seeking FDA approval for macitentan to treat pulmonary arterial hypertension. Actelion’s best-selling Tracleer was approved in 2001 for the condition and generated $1.6 billion in sales last year, according to data compiled by Bloomberg. Tracleer’s patent expires in November 2015 when the drug may face competition from low-cost generic copies.
The FDA may make a decision on whether to approve riociguat or macitentan in October.
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