Rabies Antibody Cocktail Gets Fast Tracked

FDA grants fast-track status to antibody cocktail to help prevent rabies in humans after exposure.

Posted: November 27 2007 2 a.m. EDT

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Rabies Antibody Cocktail Gets Fast Tracked
Most states require cat owners to vaccinate their pets against rabies. A new treatment aims to prevent rabies in humans after exposure to the virus.
The U.S. Food and Drug Administration’s Department of Health and Human Services recently granted a “fast track” designation to the Dutch biotechnology company Crucell N.V.’s rabies monoclonal antibody cocktail.

The status, which is reserved for drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs, is expected to facilitate the development and expedite the review process of the drug.

The company is developing the cocktail to help prevent rabies in humans after exposure.
“We are very pleased to receive the Fast Track designation for our rabies antibody cocktail,” said Jaap Goudsmit, MD, Ph.D., Crucell’s chief scientific officer. “Given the unmet medical mechanisms clearly signal the importance of expanding rabies treatment availability. People deserve to be protected against rabies.”

Phase I of the study indicates that the cocktail is well tolerated, that it provides the expected neutralizing activity and that it can be safely co-administered in combination with a standard rabies vaccine.

A second phase I study to assess the safety and efficacy of the antibody was still underway at press time.

Based on market needs, Crucell predicts that peak sales for its cocktail will exceed $300 million.

According to the FDA, most cases of rabies occur in wild animals, not domestic cats and dogs. Most states require cat owners to vaccinate their pets against rabies.

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Reader Comments

Ellen    Attleboro, MA

11/28/2007 12:51:18 AM

Intresting article!

Angela    Hamburg, NY

11/27/2007 8:21:23 PM

It is good to know that scientits are looking for ways to cure diseases that our pet and animal friends can give to us.

Sheryl    Casa Grande, AZ

11/27/2007 2:08:41 PM

Interesting article!

Donna    Limington, ME

11/27/2007 8:47:10 AM

Does that mean that there won't be a month of shots?

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