Cheshire company to test new drug in preventing kidney transplant failure

Cheshire company to test new drug in preventing kidney transplant failure

CHESHIRE — Alexion Pharmaceuticals announced Wednesday approval from the U.S. Food and Drug Administration to test a new application for an existing drug treating patients who reject organ transplants, specifically targeting kidney transplant patients.

The drug, Soliris, is currently approved by the FDA to treat two extremely rare, life-threatening blood disorders and is not approved in any country to prevent delayed graft function, or the failure of a transplanted organ to function properly in the patient’s body.

For patients undergoing a kidney transplant, delayed graft function means a lifetime of dialysis to survive.

Through a process of clinical testing starting later this year, Alexion looks to secure the approval for more widespread use of Soliris to prevent delayed graft function, or DGF, in patients.

Irving Adler, a spokesman for the pharmaceutical company, said Wednesday that the next step for Alexion is to conduct a registration study in the first half of this year.

“Soliris has the potential to lower the risk of DGF, a benefit that may have positive implications for longer-term kidney function and clinical outcomes for patients,” Martin Mackay, executive vice president and global head of research and development at Alexion, said in a statement.

“If the patients are getting the benefits we anticipate, we can file for market approval, and expect to launch Soliris for its new purpose by 2018,” Adler said.

The release cites reports by the U.S. Organ Procurement and Transplantation Network indicating that about 15 to 20 percent of donor kidneys are never used each year in the U.S. and Europe “due to the risk of poor outcomes associated with delayed graft function.”

The hope is that if Soliris can mitigate the risk of kidney transplant failure, these kidneys could be used in the patients who need them.

“For kidney transplant patients with increased risk, there is a serious unmet medical need for a treatment to prevent delayed graft function and its harmful consequences,” Mackay said.

“We’re still very much in the investigative phase,” Adler noted, however.

The FDA granted an orphan drug designation to Soliris, a status that provides a drug developer with certain benefits and incentives, including a seven-year period of marketing exclusivity if the drug is ultimately approved for its designated indication.

“We’re a company that’s focused exclusively on developing life-transforming therapies for diseases that are ultra-rare,” Adler said. “DGF is one of our lead drug development programs, so this is an important milestone for the program, and we’re very pleased that the FDA has granted this designation.”
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