Regulators OK Heart Medicine for Blacks
Regulators Thursday approved the heart drug BiDil, the first medication intended for a single race.
The Food and Drug Administration said its endorsement of the medicine for African Americans with heart failure was a step toward personalized medicine. The action came one week after an FDA advisory panel voted in favor of the pill after an intense debate about using race as the basis for treatment.
Critics contended that there was no biological basis for race and that approval of a “blacks only” drug could set a dangerous precedent. But supporters, including the NAACP and members of the Congressional Black Caucus, maintained that BiDil helped African Americans despite showing no real advantages for whites.
The drug -- a combination of two existing generic medicines that helps relax blood vessels -- prevented hospitalizations and extended the lives of black patients in a large clinical trial.
Robert Temple, the FDA’s director of medical policy, said the approval was “a striking example of how a treatment can benefit some patients even if it does not benefit all patients.”
Temple said the agency hoped to discover one day the “characteristics that identify people of any race who might be helped” by the drug.
The approval of BiDil specifically for African Americans was crucial for NitroMed Inc., a tiny biotechnology company with no other products.
The Lexington, Mass.-based company will enjoy a long monopoly on the product because its patent on BiDil as a treatment for blacks runs until 2020. Had the FDA approved BiDil for all races, the company’s monopoly would have ended in 2008 after an earlier patent expired.
The approval ends a decades-long crusade by the drug’s inventor, University of Minnesota cardiologist Jay N. Cohn. In the 1970s, he began experimenting with the generic drugs that make up BiDil: isosorbide dinitrate and hydralazine. He organized two clinical trials testing the combination in patients with heart failure, although neither product was approved for that use.
In 1987, the FDA refused to approve BiDil for general use, in part because it was inferior to so-called ACE inhibitors, another kind of drug used to treat heart failure. But data from the clinical trials suggested that black patients might benefit, so Cohn took the pill to NitroMed.
“I’m going to write a book,” said Cohn, 74, who will receive royalties on BiDil sales.
NitroMed executives weren’t available for comment, but the company issued a statement saying it looked forward to providing the drug to patients soon. The company didn’t announce a price for the drug.
News of BiDil’s approval came after the market close. In after-hours trading, NitroMed’s shares rose to $19.89, after closing at $18.97, off 72 cents, in regular trading.
Analysts say that 750,000 African Americans have congestive heart failure and that more than half of them probably would use BiDil, a market potentially worth $300 million, according to some Wall Street estimates. The co-payment on the drug was expected to be high, about $35, and some have speculated that the expense might drive some patients to substitute the generic ingredients in BiDil for the drug itself.
Liana Moussatos, an analyst at Pacific Growth Equities, said the drug could become available in three weeks and achieve sales of $11.7 million this year.
She did not expect the approval of BiDil to open a new front in drug development with products aimed at specific races. In fact, NitroMed has said it is looking for genetic information that will help it identify patients who might benefit from BiDil across racial groups.
Research into BiDil “was led by clinical data,” Moussatos said. “Race is imprecise, but what are they going to do? Deny people this drug?”
