Tweaked Glaxo drugs mired in approval delays

GlaxoSmithKline is finding one of its key strategies blocked by a new foe: the FDA. The kind of drugs that are slightly tweaked versions of existing meds, rather than built-from-the-ground-up new compounds are having a hard time getting through the agency these days. Witness Requip CR, a controlled-release form of the Parkinson's and restless-legs drug. According to a transcript of an investor meeting obtained by the Wall Street Journal, FDA asked why the CR version was better than the original. "Well, that was an unprecedented question from the FDA," Chris Viehbacher, GSK's North American pharma president said, according to the transcript. GSK ended up withdrawing its CR app.

This past weekend, GSK did get the nod for its Requip XL, which can be taken once a day rather than three times, for use in Parkinson's. That approval comes a little too late for the company to do what it likes to do with line-extension meds: convert patients from the old brand-name drug--in this case plain old Requip--to the new form before the old one goes off patent. Requip XL's app was delayed at the FDA, and generic Requip has already hit the market.

Will the same thing happen to GSK's Lamictal extension? The original Lamictal, used to treat epilepsy and bipolar disorder, will see generic competition soon--probably next month. And GSK is still waiting for the FDA to act on Lamictal XR.

For its part, the FDA says it takes each drug app on its own merits, not considering what else might be on the market. But analysts say the agency is focusing its limited resources on more innovative products. "The whole industry is finding it difficult to get through the FDA with line extensions," one analyst told the WSJ, "because the FDA is understaffed and focusing on things they think are more innovative and important." 

- see the WSJ article