מתוך אתר medicontext.co.ilWASHINGTON (Reuters Health) -The US Food and Drug Administration (FDA) approved on Wednesday Schering-Plough's application to label Rebetol (ribavirin) for use in combination with Peg-Intron (pegylated interferon alpha-2b).

Schering-Plough filed the labeling change with the FDA in January and the application received a fast-track review. Rebetol was previously approved for use in combination with Intron A (interferon alpha-2b).

Peg-Intron, a longer-acting version of Intron-A, was created using a polyethylene glycol (Peg) molecule developed by Piscataway, New Jersey-based Enzon and approved as a stand-alone product in January. All three drugs are sold by Schering-Plough.

Approval of the combined use of Peg-Intron and Rebetol allows for adult hepatitis C patients with liver disease to follow a once-a-week dosing schedule, rather than the three-times-weekly regimen required with the standard therapy.

According to the FDA, Peg-Intron with Rebetol is somewhat more effective than Rebetol in combination with Intron A. At the end of 24 weeks, 52% of patients on the Peg-Intron combination had undetectable levels of the hepatitis C virus, compared with 46% of patients on the Intron A combination, the agency noted. In patients with a particularly difficult to treat variant, sustained response was 41% in the Peg-Intron group versus 33% in the Intron-A group, the FDA said.

The path for Wednesday's approval was paved late last month when the FDA cleared Rebetol's "unbundling" from Intron-A, allowing it to be sold in a separate package.

Consumer groups in general lauded the unbundling, pointing out that it allowed treatment to be individualized to best suit each patient. But the Hepatitis C Action & Advocacy Coalition recently expressed concern that Schering-Plough will maintain a corner on the market and keep prices high. "Schering is likely to set an exorbitant price for Rebetol while charging very little mark-up in their combinations kits," the group said. "This would discourage off-label use of Rebetol with other interferons."

Schering-Plough officials refused to comment on the issue, saying that prices have yet to be set. But spokesman Robert J. Consalvo told Reuters Health that the company does expect the latest approval to spur sales of both Rebetol and Peg-Intron. "One would have to assume that would be the preferred way for physicians to prescribe treatment," he said.

Schering-Plough hopes to begin shipping unbundled Rebetol capsules this fall.

On the New York Stock Exchange, shares of Kenilworth, New Jersey-based Schering-Plough rose 0.17 to close at 38.35. Shares of Enzon, which receives royalties on the sale of Peg-Intron, shot up 4.86–or more than 8%–to close at 64.96 on the NASDAQ exchange.