Shire seeks hearing to break impasse on Proamatine
* Unusual step to seek FDA approval for low blood pressure drug
* Shire has no financial interest in now generic drug
LONDON, Sept 22 (Reuters) - Britain's Shire said it would take the unusual step of appealing to a public hearing to break an impasse with U.S. regulators in gaining final approval for Proamatine, a treatment for low blood pressure.
Shire gained Proamatine, which is used by people whose blood pressure drops when they stand, a condition known as symptomatic orthostatic hypertension, through acquisition in 2000.
However, the medicine has been made by five generic drug companies since 2003.
Proamatine was approved in 1996, but the FDA required further trials, completed by Shire, which the regulator said were inconclusive.
"While we continue to work with the FDA to design trials that further confirm the clinical efficacy of Proamatine, we've reached an impasse," Shire's senior VP for R&D Jeffrey Jonas said in a statement on Thursday.
"We now believe the fastest way to get the final approval for this medicine is to present our data at a public hearing, thereby sparing patients the additional hardships of clinical trials."
He said Shire was doing everything it could to keep the medicine on the market so patients could continue to access it.
Shire, which no longer has any financial interest in the drug, said it believed the trials and 15 years of clinical experience had established its efficacy. (Reporting by Paul Sandle; Editing by Helen Massy-Beresford)
- Tweet this
- Share this
- Digg this