While the Medicines Agency had unanimously accepted the use of Avastin® to treat age-related macular degeneration, its manufacturer, the Roche laboratory, is still firmly opposed to it. Ignoring the wishes of the laboratory, the ANSM announces that the treatment will indeed be available from September.
Last March, the health authorities thought they had unblocked the situation that paralyzed the temporary use ofAvastin®an anti-cancer treatment also effective in treating AMD. Only, on June 23, the manufacturer laboratory Roche responded to the Medicines Agency, in “reiterating its opposition to such an implementation when several duly authorized therapeutic alternatives are available in AMD“. However, Avastin® injections are thirty times cheaper than those of the only alternative for AMD, Lucentis®, marketed by the Novartis laboratory.
Although its effectiveness had been proven as early as 2012, Avastin® was not used because financial agreements between the two pharmaceutical companies. Following negotiations deemed illegal with Novartis, Roche had officially asked not to give marketing authorization to its own product, depriving thousands of patients of less expensive treatment. Despite the recommendations of the ANSM, Roche therefore reaffirms its choice.
The Medicines Agency ignores Roche’s statements
The Swiss group points out that Avastin® “is not authorized in any country in the world for ophthalmic use” and declares that he “cannot assume responsibility for setting up and monitoring the use of Avastin® that it does not recommend“. The only condition for Roche to accept this use: that the ANSM take full responsibility for Avastin®. The same day, the ANSM reacted, reminding Roche of its legal obligations in terms of public health and the monitoring of patients treated with its own products.
Two days later, the ANSM reaffirmed its position, announcing that Avastin® would indeed be available, from September, against the opinion of the laboratory. Usage will be “established for a period of 3 years, renewable in particular depending on the efficacy and safety data that will be taken from patient monitoring“, adds the Agency. For safety conditions, the preparation of this product must imperatively be done in a hospital pharmacy, in particular to avoid contamination by bacteria during the production of syringes suitable for ocular injections.