FLORENCE, 28 Aug (APM) - Italy is allowing access to Gilead's Veklury (remdesivir) for Covid-19 treatments on a patient-by-patient basis only due to extremely limited supplies, medicines agency AIFA has announced.
The European Commission approved conditional authorisation of the drug in July (APMHE 68030). However, there are signs that countries are having difficulties in meeting demand from hospitals with Spain announcing recently it is close to running out of stocks (APMHE 68636).
In a Thursday statement, Italy's AIFA said that Veklury can be supplied only as an Emergency Support Instrument (ESI). It advised that €63 million has been provided to pay for enough quantities to treat around 30,000 people in Europe.
The medicines agency said: "In consideration of the extremely small stocks, access to the drug will be managed in the initial phase until the end of September by means of a nominal request to AIFA for each patient."
The regulator added that, during the initial phase, which will run up to October, only requests for patients with a clinical condition corresponding to the European Commission's authorised indication will be accepted for a treatment cycle of five days, in line with the best scientific evidence available.
According to AIFA, the European Commission has announced that a joint procurement agreement is being prepared to procure further supplies of the drug, in order to meet the needs and requirements from October onwards.
The medicines agency said that each request for Veklury will be dealt with urgently and supply guaranteed within hours, once the clinical conditions of the patient have been verified. The health ministry, which is storing the stocks of available Veklury, will ensure two deliveries a day are made to fulfill the orders from hospitals.
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