Despite the admission of the Roche laboratory’s impotence to be able to condition this treatment, the ANSM published the RTU of Avastin in AMD. It will come into force on September 1st.
Since last March, France has authorized the drug Avastin for the treatment of age-related macular degeneration (AMD). In addition to being thirty times less expensive than Lucentis, this anticancer drug has shown equal effectiveness in the treatment of this pathology. However, at the present time, the treatment remains inaccessible to patients because the Roche laboratory is still opposed to the French RTU (Temporary Recommendation for Use) arguing a risk to the health of patients.
Entry into force of the RTU on September 1
Faced with the attitude of the Roche laboratory, the National Medicines Safety Agency (ANSM) remains firm, as evidenced by Press release (ANSM). In fact, the health authority announces that the RTU concerning the off-label use of Avastin “will enter into force as of September 1, 2015”. What to put pressure on the pharmaceutical laboratory.
The ANSM also recalls that the use of Avastin is subject to “a protocol for use and monitoring which defines the practical conditions for the prescription, preparation, delivery and administration of the drug (prescription and administration by hospital ophthalmologists, procedures for preparing syringes in sterile conditions by pharmacies for internal use, dosage, prescription criteria, etc.) as well as the procedures for monitoring patients treated in this context ”.
An RTU established for 3 years
Finally, the Agency recalls that the Avastin RTU is established for a period of 3 years, “renewable in particular according to the efficacy and safety data which will be obtained from the monitoring of patients. Annual summary reports of this monitoring will be produced by the laboratory and published by the ANSM on its website. “
Roche ready to give his license in ophthalmology
Contacted by Why actor a few days ago, Roche replied: “we are simply not in a position to meet this obligation. We have been opposed to RTU from the start, not out of dogmatism, but because we do not have the technical means to repackage Avastin for ophthalmological use ”.
The laboratory added: “we do not have the necessary production lines nor the distribution centers which have the legal capacity to decondition the primary packaging. Our factories do not produce eye medicine ”.
Proof of its good faith, the industrialist affirmed to be ready “to license the product to a third party, without financial advantage on our part, under the responsibility, for example, of the Hospices Civils de Lyon which became promoter of the trial, or to someone who may have pharmaceutical status ”.
“The implementation of the RTU is the responsibility of the laboratory which holds the marketing authorization,” recalled the ANSM contacted this Friday by Why actor. The laboratory must therefore make Avastin available on the date we have just indicated. “
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