Protocols

EMA endorses Teva’s migraine drug; Disaster prone CTI BioPharma rescinds EU application for pacritinib

→ The EMA was busy on Friday. The European drug regulator, which is currently in the process of shifting its headquarters to Amsterdam from London, recommended the approval of Teva’s migraine-prevention drug, Ajovy. A final decision is expected in the first half of this year, and if approved the treatment drug will be the first and only anti-CGRP medicine in the EU with both quarterly and monthly dosing options, the Israeli drugmaker said. CTI BioPharma, however, had bad news to report on the European front for its myelofibrosis drug pacritinib. The notoriously failure-prone drug developer announced it was withdrawing an application to market the drug in the EU, following discussions with the EMA. Last year, Shire backed away from a partnership with the ill-fated company, following a mixed data readout from a pivotal study that was previously put on a full clinical hold — under the behest of the FDA — after the death of several patients. The company’s shares $CTIC tumbled more than 15% in early Friday trading.

→ Separately on Friday, the EMA also laid out guidance to help biopharma companies prepare for Brexit, so as to ensure supply is not disrupted — on the assumption the UK will become a third country as of 30 March 2019. For pre-submission meetings regarding human and animal drugs requested from last October, the EMA will engage with manufacturers via teleconference or virtual meetings. Between 11 February and 15 March 2019, no such meetings for initial marketing authorisation applications will take place, while the EMA moves to its new home in Amsterdam, it said.

→ On Thursday at a parliamentary committee meeting, UK health and social care secretary Matt Hancock said the British government was prioritizing medicines over food if a no-deal Brexit would make it tricky to import products in either category of goods. Last year, Hancock  asked drug suppliers to keep six weeks worth of medicines stockpiled in addition to their buffer stocks and last month the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that in the event of a no-deal, the UK would be no longer be part of the EMA umbrella, and that regulatory submissions for drugs would be made directly to the MHRA.


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