Bayer Lung Drug Should Be Approved at Low Dose, FDA Says

Bayer AG (BAYN)’s experimental treatment for two forms of pulmonary hypertension is being recommended for approval by U.S. regulatory staff at a lower dose than what the company sought.

Bayer’s riociguat improved the distance patients can walk during a six-minute test in clinical trials, Food and Drug Administration staff said today in a report ahead of a meeting of agency advisers Aug. 6. 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.

Chronic pulmonary thromboembolic hypertension can cause the vessels that carry blood from the heart to the lungs to become hard and narrow, making the heart work harder to pump, the National Institutes of Health said on its website. 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.

“This drug is approvable so long as its dosing algorithm is modified,” Preston Dunnmon, an FDA reviewer, wrote in the report.

Chronic pulmonary thromboembolic hypertension affects about 5,000 people each year and can now only be treated with a complex surgery, the Cleveland Clinic says on its website.

Dosing Recommendations

Bayer was 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 milligrams 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.

Bayer also is seeking U.S. approval for riociguat to treat pulmonary arterial hypertension, which is high blood pressure that can cause arteries in the lungs to constrict abnormally.

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.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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