Indian authorities withdraw alert on off-label use of Roche's Avastin
- The Drug Controller General of India (DCGI) has withdrawn an earlier alert warning against off-label opthalmic use of Roche's cancer drug Avastin. It requested the All India Opthalmological Society and Vitreo Retinal Society of India to formulate guidelines for the safe and effective use of Avastin for opthalmic purposes.
- In mid-January, two states in India halted sales of Avastin after off-label use led to vision problems and blindness in 15 patients in the state of Gujarat. Avastin is frequently used to treat wet age-related macular degeneration (AMD), despite not being approved for that purpose.
- In reaching its decision to lift the alert, the DCGI noted the World Health Organization has placed Avastin(when used for ophthalmological preparations)on its List of Essential Medicines.DCGI also cited the over 2,500 studies proving the safety and efficacy of Avastin for intravitreal use
Age-related macular degeneration accounts for 8.7% of all blindness worldwide. It represents a significant burden in both developed and developing countries. However, Avastin is often chosen over approved treatments like Novartis' Lucentis because of its low cost. In India, Avastin is 40 times cheaper than Lucentis, according to the DCGI.
"This would put less financial burden on patients and prevent blindness of many," the DCGI said in its letter.
In September 2015, France made headlines when it put a law into effect allowing Avastin to be used to treat AMD. Despite pushback from the pharmaceutical industry, France's regulatory body (ANSM) stood its ground.
Roche has emphatically reiterated Avastin is not approved for intraocular use by the FDA or the Indian government, even though it acknowledges that Avastin has long been used for treatment of AMD.
By proposing new guidelines for the proper off-label use of Avastin, the DCGI is addressing safety concerns head-on.
- Economic Times of India Indian drug regulator backs off over use of Roche’s Avastin