
Avastin faces greater scrutiny over eye disease use
pharmafile | September 23, 2011 | News story | Sales and Marketing | avastin, macular oedema
The use of Roche’s Avastin to treat eye disease has come under greater scrutiny after a series of infections in patient receiving the cancer drug.
The US Department of Veterans Affairs (VA), a national body that provides patient care and federal benefits to military veterans, has said it will no longer allow the off-label use of Avastin (bevacizumab) for wet age-related macular oedema.
“The Department of Veterans Affairs has ceased ophthalmologic use of Avastin pending the results of an ongoing investigation and will advise its physicians to consider alternate therapies,” the VA said in a statement.
“Once the investigation is complete, VA will reassess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance.”
Currently Novartis’s Lucentis (ranibizumab) is licenced to treat wet AMD in the US, but costs far more than Roche’s drug.
Both treatments are chemically similar, but Roche holds the licensing rights to Lucentis in the US, disincentivising them to develop Avastin for wet AMD, as they would be undercutting their own drug.
The FDA is currently conducting clinical trials to assess whether Avastin could be used off-label instead, but has recently issued a safety alert for the practice.
This came after a number of serious eye infections occurred in Florida when patients were given Avastin instead of Lucentis.
In this situation, it was the repackaging of Avastin that was thought to cause the infections, as the drug is distributed in vials that are too large for wet AMD patients, and must be put into smaller containers.
European lobby groups call for code of practice for off-label prescribing
Meanwhile, in Europe a number of lobby groups have banded together to call for new rules for off-label prescribing.
The European Alliance for Access to Safe Medicines (EAASM), the European Federation of Neurological Associations, the European Men’s Health Forum and the European Depression Association released a joint statement asking for tighter controls.
“Our message is enough is enough,” said Jim Thomson, Chair of the EAASM. “The FDA was able to act because it was made aware of the problem. In Europe it’s a matter of chance as to whether the regulatory authorities are made aware of similar problems because there is no mandatory mechanism to report adverse events in medicines used this way.”
The groups said that if the practice were to continue, there should be a mandatory system to register adverse reactions for off label or unlicenced drugs by introducing a professional code of practice, as this currently does not exist.
The patient organisations involved have put their name to the consensus statement and will be seeking meetings with European regulatory and professional bodies over the coming weeks, they said.
Ben Adams
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