Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Hamburg FDA May Look Favorably On Anti-infectives For Serious Conditions

Executive Summary

Anti-infective drug developers may see new opportunities for a favorable regulatory review climate for products for a few serious conditions, based on FDA's public health-oriented top management team under new Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein

You may also be interested in...



Antibiotic updates

The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)

Antibiotic updates

The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)

Commissioner Margaret Hamburg: Moving FDA Beyond A Regulatory Agency

Of the leading candidates for FDA commissioner in the Obama administration, Margaret Hamburg seemed among those with the least relevant experience - an illustrious career to be sure, but one that lacked a decision-making role involving medical products

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS051503

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel