Federal regulators Friday approved a new antibiotic to fight intra-abdominal and urinary tract infections and a three-drug cocktail to treat the liver-ravaging hepatitis C virus, giving a holiday boost to patients and to a pair of Massachusetts biotech companies.
The antibiotic, developed by Lexington's Cubist Pharmaceuticals Inc., has the brand name Zerbaxa. Given through infusions in hospitals, it is the first in a new generation of drugs aimed at a class of Gram-negative bacteria resisting today's antibiotics. Such bacteria account for most "superbug" infections that cause an estimated 23,000 deaths in the United States annually.
The product received recognition after it was given Qualified Infections Disease Product status by the FDA for serious or threatening medical issues and how the agency's drive to increase antibacterial and antibiotic options for patients, according to the Pharmaceutical Journal.
Zerbaxa combines ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor.
"We are very pleased to arm physicians with Zerbaxa in the battle against Gram-negative bacteria, where few treatment options exist. The approval...demonstrates the agency's commitment to make available new antibiotics that address this serious public health threat," said Robert J Perez, the company's president and chief operating officer, in a news release.
The drug works as a neuraminidase inhibitor, such as oseltamivir (Tamiflu) and zanamivir (Relenza.) However, what makes it different is that instead of being given as a shot, zanamivir is inhaled.
While the drugs hold promise against serious diseases, they come at a price. The wholesale "sticker" price for Viekira Pak will be $83,319 per patient for a 12-week treatment regimen. That is slightly less than the best-selling hepatitis C medicine, Sovaldi.
The price for Zerbaxa was not immediately disclosed by Cubist. Hospital antibiotics typically cost between $200 and $300 a day per patient. Cubist's top-selling antibiotic, Cubicin, which treats a different family of bacteria, is priced at $250 to $320 a day depending on the kind of infection it treats, or a total of $3,500 to $4,480 for a 14-day treatment course.
Luly said Enanta will invest the funds in research and development of other medicines to treat hepatitis C and other as yet unspecified diseases.
"In the history of any company, the first drug approval is historic," Luly said. "We're so lucky we can work on something that ultimately leads to a cure. It's a great thing for hepatitis C patients around the world."