U.S. advisers back 1st drug from DNA-altered animals

By Susan Heavey

ROCKVILLE, Maryland (Reuters) - The first drug made using genetically engineered animals to near U.S. approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.

GTC Biotherapeutics Inc’s experimental anticlotting therapy, called Atryn, is made using a human protein gathered from female goats bred to produce it in their milk.

GTC is seeking approval to sell the intravenous therapy to prevent excessive blood clots in patients with an inherited disorder.

Company data showed the drug was safe and effective, a majority of the Food and Drug Administration’s 19-member panel voted. The FDA will consider the advice in making its decision, expected by February 7.

“This will… set a precedent for what will happen in the future,” said Dr. Richard Colvin, the panel’s consumer representative and a clinical assistant in medicine at Massachusetts General Hospital.

But some genetic-safety and animal advocates at the meeting expressed concern about the use of so-called transgenic animals despite the drug’s benefits, saying more information is needed from the agency about genetically engineered animals.

The FDA issued preliminary guidelines in September about how it would regulate animals whose DNA has been altered and called for public comment, but it has not yet issued final details.

Approving Atryn “would be a back door way to approve transgenic animals,” said Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety.

Still, FDA officials said they were seeking advice on the specific product, not the larger issue of generically-altered animals. They added that the final regulations on such animals would be released soon.

Several patients and family members at the advisory meeting urged the FDA’s approval of Atryn regardless of the transgenic issue.

Karen Janes, whose daughter died after a 7-inch-long clot, said it could help her remaining daughter live longer and have children. “I don’t care how it’s made,” the New Mexico resident told the panel.

Between 60,000 and 600,000 people in the United States have the excessive clotting disorder, known as hereditary antithrombin deficiency, according to GTC.

GTC has estimated Atryn could generate up to $40 million to $50 million in U.S. annual sales in its first five years on the market. Shares of the company were halted Friday for news pending.

The goats used to make Atryn are bred using cells injected with human DNA. The company has a herd of about 200 at its Massachusetts facility, which are otherwise normal and screened for viruses, GTC said.

In a statement, company officials said the panel’s vote helps get their key product closer to market. The drug is the biotech company’s first therapy to reach the FDA for review.  Continued…


Related Posts:

TOKYO (Reuters) - A study group for Japan’s top safety watchdog said cloned animals are safe for food, the first step in a series of decisions needed before the watchdog makes recommendations to the government. With several meetings pending by a higher-level committee of experts, it will take months before the Food Safety Commission reports its

Full Post: Japan study group says cloned animals safe for food

By Lisa Richwine GAITHERSBURG, Maryland (Reuters) - A U.S. advisory panel has unanimously backed a new version of a Genzyme Corp injection to relieve knee pain from osteoarthritis. The panel of experts voted 5-0 on Tuesday to urge the Food and Drug Administration to approve Synvisc-One, a single-dose formulation of the company’s Synvisc injection. The FDA usually

Full Post: U.S. advisers back Genzyme therapy for knee pain

By Jasmin Melvin WASHINGTON (Reuters) - The U.S. food supply is at risk of being invaded by unapproved imports of genetically modified crops and livestock, a USDA internal audit report released Wednesday said. The report, released by the U.S. Agriculture Department’s Office of Inspector General, said the USDA does not have an import control policy to regulate

Full Post: USDA unable to weed out unapproved modified foods

WASHINGTON (Reuters) - U.S. health regulatory staff have questioned whether there are enough data to show that Female Health Co’s latest condom for women prevents pregnancy and sexually transmitted diseases, according to documents released on Tuesday. The Chicago-based company is seeking Food and Drug Administration approval to sell its new version, called the FC2 Female Condom,

Full Post: FDA staff debate data for new female condom

NEW YORK (Reuters) - New data do not signal any heart risks with Takeda Pharmaceutical Co Ltd’s experimental drug to treat acid build-up in patients with gout, a top U.S. Food and Drug Administration official said in a document released on Thursday. Takeda is seeking U.S. approval to sell its drug febuxostat for chronic gout patients

Full Post: No heart risk seen with Takeda gout drug: FDA

Site Navigation

Most Read



  • kinwrite.com@gmail.com