Of NDAs and Companion Diagnostics

According to Bloomberg, Novartis AG’s two-year effort to revive its Prexige pain pill after it was rejected by U.S. regulators has spurred the development of the first genetic test to identify who will develop drug side effects.

Novartis may re-submit a marketing application for Prexige to the Food and Drug Administration this year along with a genetic test that can detect who may suffer the liver damage that arises in some patients, said Michael Nohaile, the head of Novartis’s new molecular diagnostics unit. The test would be obligatory for patients to obtain a prescription, a first for the drug industry, he said.

“This is a very real opportunity now,” Nohaile said in an interview at the company’s Basel, Switzerland, headquarters. “We already have an agreement from many authorities that the data are good and that they are excited about it. This could be a launch this year or next.”

While a growing number of treatments are marketed as personalized medicine, with genetic tests to allow doctors to determine which patients will benefit, Prexige would be the first with a test to ensure safety. Drugmakers see testing as a way to persuade regulators and insurers to approve and pay for the medicines by showing that they’re effective.

Novartis is counting on the test to reassure doctors and patients. With a test showing that a certain drug will be safe, Nohaile said, “We can go to doctors and say it moves it out of the realm of choice into the realm of malpractice if you don’t use this drug.”

Click here for the entire Bloomberg article.