Avandia to face European safety review
pharmafile | July 12, 2010 | News story | Sales and Marketing | Avandia, GlaxoSmithKline, diabetes
GlaxoSmithKline’s type II diabetes drug Avandia, the subject of safety concerns since its launch in 2000, is to be reviewed again.
The Committee for Medicinal Products for Human Use (CHMP) is to look at the benefit/risk profile of Avandia (rosiglitazone) following the recent publication of an observational study and a meta-analysis of data.
The European regulatory advisors will review and discuss the data with GSK during a scheduled meeting next week.
Previous reviews have found the benefits of rosiglitazone outweigh its risks and GSK has already strengthened safety warnings following European regulators’ recommendations.
It has always been contraindicated in patients with heart failure or a history of heart failure, and updates now include warnings and contra-indications for patients with heart problems.
In 2007 the drug was hit by a safety scare after concerns over cardiovascular side effects, losing sales in the US in particular.
The following year the CHMP decided that the drug “retained a small, if diminishing, place in diabetes type II therapy”.
But it will now decide whether or not the marketing authorisations for the Avandia franchise – which includes its metformin combination Avandamet and glimepiride combination Avaglim – should be revoked, suspended or changed.
“GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate type II diabetes patients,” said Tony Hoos, GSK’s European medical director.
“It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients,” adds Hoos.
Patients are advised not to stop taking Avandia without consulting their doctor.
Meanwhile US regulator the FDA has posted a GSK review of cardiovascular safety data on Avandia, which will be reviewed in a meeting this week.
“Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death,” said Murray Stewart, GSK vice president for clinical development.
Adam Hill
Related Content
MetP Pharma releases positive data on intranasal semaglutide administration
MetP Pharma has released new data highlighting the advantages of its MetP technology in delivering …
AOTI diabetic foot care therapy to be used by NHS
Effective from September 2025, AOTI’s Topical Wound Oxygen (TWO2) therapy has been awarded inclusion in …
Recce Pharmaceuticals reports positive phase 2 data for skin infection drug
Recce Pharmaceuticals have announced positive patient data from its phase 2 clinical trial into RECCE …
