Use of the monoclonal antibody bamlanivimab in Italy for the treatment of Covid-19: no free offer from Eli Lilly, only request for approval for sale
In recent days, some articles have been published in national newspapers which give rise to resistance that AIFA allegedly opposed the use in Italy of a drug, the monoclonal antibody Bamlanivimab, produced by the pharmaceutical company Eli Lilly on the national territory, and which the same company would have offered for free without getting a response. These are misleading and baseless claims.
In this regard, the following is specified:
- AIFA has never received any proposal for free transfer, compassionate use or supply for clinical studies of the monoclonal antibody Bamlanivimab from the Eli Lilly company.
- At the beginning of October, the company made a general willingness to cooperate with the authorities to identify ways of using the drug in Italy, without ever offering free batches of the product. This also after an explicit request made by the AIFA representatives in a meeting held on 29 October with the participation of the Agency's Technical-Scientific Commission, convened specifically to demonstrate its full willingness to investigate any sustainable possibility of accessing new treatments.
- On November 20, the Eli Lilly company presented an offer to the AIFA for the purchase of the drug by the NHS, delivering a contract hypothesis to the COVID-19 emergency commissioner structure on November 25.
- Monoclonal antibodies require European approval, while the Eli Lilly company has proposed a drug approval procedure as an exception to these procedures. EMA expressed a very cautious opinion on the possibility of approving Bamlanivimab based on the phase 2 study showing moderate benefits and requested further supporting data.
- The request for drug approval pursuant to a special provision of pharmaceutical legislation (art. 5 paragraph 2 of directive 83/2001, as implemented in Italy by Legislative Decree 219/2006) is not acceptable in the face of a epidemic in which all EU states share the same problem and in which we therefore expect a common European effort to overcome it, as well shown by the recent EMA approval of the anti-COVID-19 vaccines. For this AIFA has expressly suggested to the company the opportunity to submit an authorization request to the EMA.
It is specified that the emergency authorization granted in the USA by the FDA provides for a lower level of scientific evidence than the approval (complete or conditioned) carried out by EMA.
AIFA is committed to guaranteeing - in a clear and transparent way - access to all medicines with proven efficacy and safety, based on the best scientific evidence, to protect citizens and patients and the sustainability of the National Health System.