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Friday, 29 January 2010 10:04 GMT
FDA judges Theravance response incomplete; company unsure what agency wants
LONDON, Jan 29 (APM) - Theravance said U.S. health regulators have deemed incomplete the additional data that the company had submitted in support of telavancin for nosocomial pneumonia (NP).
On Thursday, the company said in a statement that the FDA also suggested a design for new clinical trial(s) and suggested the company request a meeting with the agency.
"It is unclear at this point what additional information the FDA will require to complete their review of the nosocomial pneumonia new drug application," Theravance chief executive Rick Winningham said.
There was no guidance provided regarding the primary clinical efficacy endpoint suitable for approval, the size or number of additional studies required, or statistical methods for evaluation of clinical results, the company added.
Winningham added: "The ATTAIN studies included over 1,500 patients in total and are the largest randomised double blind studies that have been submitted to the FDA for the evaluation of a new agent to treat NP due to Gram positive organisms.
"These studies were designed and conducted in accordance with the current draft FDA guidelines for clinical trial design in nosocomial pneumonia which include clinical cure as the primary efficacy
endpoint and mortality as a secondary endpoint.
"Importantly, each study met its primary efficacy endpoint of clinical cure. Further, since the FDA appears to be treating mortality as a primary endpoint, there was no statistically significant difference in all-cause mortality between the treatment groups," he added.
In November, the U.S. Food and Drug Administration issued a complete response letter for the U.S. group's drug and asked for additional data to approve the drug.
On Thursday, the company said the FDA, in its letter had said Theravance's response to the November complete response letter for the New Drug Application was "incomplete and that the review clock will not start until the FDA receives a complete response."
Telavancin was approved in the U.S. last November as a treatment for complicated skin and skin structure infections under the brand name Vibativ.
Theravance, which discovered the antibiotic, is collaborating with Astellas in the U.S. marketing of the drug for the first three years following launch.
Astellas withdrew its European filing of telavancin in 2008 following an unfavourable review by the European Medicine Agency's CHMP. The Japanese company said at the time it hoped to refile with additional data.
nh/ra
[17935] 29/01/2010 10:04 GMT - AIDS IMMUNO
On Thursday, the company said in a statement that the FDA also suggested a design for new clinical trial(s) and suggested the company request a meeting with the agency.
"It is unclear at this point what additional information the FDA will require to complete their review of the nosocomial pneumonia new drug application," Theravance chief executive Rick Winningham said.
There was no guidance provided regarding the primary clinical efficacy endpoint suitable for approval, the size or number of additional studies required, or statistical methods for evaluation of clinical results, the company added.
Winningham added: "The ATTAIN studies included over 1,500 patients in total and are the largest randomised double blind studies that have been submitted to the FDA for the evaluation of a new agent to treat NP due to Gram positive organisms.
"These studies were designed and conducted in accordance with the current draft FDA guidelines for clinical trial design in nosocomial pneumonia which include clinical cure as the primary efficacy
endpoint and mortality as a secondary endpoint.
"Importantly, each study met its primary efficacy endpoint of clinical cure. Further, since the FDA appears to be treating mortality as a primary endpoint, there was no statistically significant difference in all-cause mortality between the treatment groups," he added.
In November, the U.S. Food and Drug Administration issued a complete response letter for the U.S. group's drug and asked for additional data to approve the drug.
On Thursday, the company said the FDA, in its letter had said Theravance's response to the November complete response letter for the New Drug Application was "incomplete and that the review clock will not start until the FDA receives a complete response."
Telavancin was approved in the U.S. last November as a treatment for complicated skin and skin structure infections under the brand name Vibativ.
Theravance, which discovered the antibiotic, is collaborating with Astellas in the U.S. marketing of the drug for the first three years following launch.
Astellas withdrew its European filing of telavancin in 2008 following an unfavourable review by the European Medicine Agency's CHMP. The Japanese company said at the time it hoped to refile with additional data.
nh/ra
[17935] 29/01/2010 10:04 GMT - AIDS IMMUNO
