UPDATE 1-Theravance: FDA asks for more data on telavancin
* Says FDA asks for more data on experimental antibiotic
* Says FDA asks for label revisions, safety update
* Shares down almost 9 percent
Feb 26 (Reuters) - Theravance Inc (THRX.O) said the U.S. health regulators asked for more study data, label revisions and safety update on its experimental antibiotic for serious skin infections, sending its shares down about 9 percent after the bell.
The drug, telavancin, is currently also being tested as a treatment for hospital-acquired pneumonia (HAP).
In a complete response letter to the company, U.S. Food and Drug Administration asked for data on patients with certain renal risk factors from the complicated skin and skin structure infections study and HAP studies.
The FDA also asked for data to ensure the drug's benefits outweigh the risk of it causing malformations of an embryo or fetus. A boxed warning related to the risk will be included in the package insert of the drug noting that females of childbearing potential should have a negative pregnancy test prior to administration, the company said. The required label revisions include monitoring of renal function and cautionary language regarding the use of telavancin in patients with certain renal risk factors. However, the regulators did not ask for additional trials.
Theravance shares were trading at $12 after the bell. They closed at $13.13 Thursday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Himani Sarkar)
