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CHMP Begins Rolling Review Of Gilead’s Remdesivir

As of this morning – Friday May 1 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 171,253 with 26,771 deaths.

The European Medicines Agency’s human medicines committee (CHMP) says it has started a ‘rolling review’ of data on the use of Gilead’s antiviral remdesivir for the treatment of coronavirus disease (COVID-19).

The rolling review is used by the Agency to accelerate the assessment of a promising investigational medicine during a public health emergency, such as the current pandemic.

Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure. In the case of a rolling review, CHMP Rapporteurs are appointed whilst development is still ongoing and the Agency reviews data as they become available.

Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting around two weeks depending on the amount of data to be assessed. Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed under a shortened timetable.

While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that the move will allow the EMA to complete its assessment significantly earlier compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.

The CHMP’s decision to start the rolling review of remdesivir is based on preliminary results from the ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19.

However, the EMA stressed that it has not yet evaluated the full study and thus is it too early to draw any conclusions regarding the benefit-risk balance of the medicine.

Remdesivir is not yet authorised in the European Union but is available to patients through clinical trials and compassionate use programmes.

Source: http://www.pharmatimes.com/news/chmp_begins_rolling_review_of_gileads_remdesivir_1339365

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