No More Pig Virus Tests for Solvay Drug

by 5m Editor
4 December 2008, at 11:24am

US - Solvay Pharmaceuticals Inc does not need to develop additional tests to screen out three viruses from its pancreatic enzyme drug Creon, which is made from pig glands, a US advisory panel said on Tuesday (2 December 2008).

So far it is unclear whether people taking the drug could get sick from the three animal viruses -- porcine parvovirus, and two types of porcine circovirus -- so more tests are not warranted, the Food and Drug Administration (FDA) panel of outside advisers said.

"We feel like there is a very low potential risk for patients," Peter Havens, a panel member and pediatrician at the Medical College of Wisconsin.

Solvay Pharmaceuticals, a unit of Brussels-based Solvay SA, is seeking FDA approval to continue to sell its Creon capsules in the United States for patients with exocrine pancreatic insufficiency, reports Reuters.

Creon is made from pig glands, which like other animal products may carry various viruses such as influenza and hepatitis and transmit them to humans.

Solvay already takes steps in manufacturing Creon to kill numerous viruses or minimize the risk of infection, and so far it has not seen a pattern of illness, company officials told the panel.

"We believe the risk is very, very low," with the three new viruses, said Earl Sands, Solvay's vice president for research and development.

Most panelists agreed, saying there was not enough data to call for additional tests. There also are no other emerging viruses that warrant routine screening, the majority said in a separate vote.

"Right now, I don't see enough information to apply that to patients at all... I think it needs to be studied, but I'm not at a point where I think it needs to be put under regulations," said panelist George Ferry, a pediatrician at Baylor College of Medicine in Texas.

Creon and other related drugs provide a blend of digestive enzymes needed to treat pancreatic insufficiency, a relatively rare condition that prevents people with cystic fibrosis, chronic pancreatitis and other diseases from properly digesting food and absorbing nutrients.

Such enzymes have been on the market for so long they were never required to undergo FDA approval, but the agency in 2004 ordered manufacturers to formally prove their drugs were safe and effective.

Companies must win FDA clearance by April 2010 or halt sales. Solvay is the first manufacturer to get close enough to an FDA decision to warrant a public hearing.

The FDA will weigh the panel's advice before making its decision, which the company expects by the end of the year.

At the meeting, FDA officials said they are not planning to ban the products but are looking at ways to help mitigate the possible risk of infection.

The FDA's decision on Creon is likely to have implications for other manufacturers of pig-based pancreatic enzyme drugs. Other products include K-V Pharmaceutical Co unit Ethex Corp's Pangestyme and privately-held Axcan Pharma Inc's Ultrase, among others.

Altus Pharmaceuticals Inc is also developing a rival drug called Trizytek that is produced from microbes rather than pig glands. Other pancreatic enzyme drugs are also derived from vegetables and cows.

Panel members and the FDA agreed the products are effective. But some panelists said the company should test for the three viruses until more is known about them.

"I think there is a dearth of information," said Colin Parrish, a professor of virology at Cornell University's College of Veterinary Medicine.

Many panelists also said such animal-based enzymes should carry cautions similar to those found on meat products warning consumers about the risk of illness if not cooked properly. Solvay should also come up with a detailed plan to monitor possible risk of emerging infections in animals, they said.