Euro Roundup: EMA recommends monkeypox vaccine as multifront response advances

RoundupsRoundups | 28 July 2022 |  By 

The European Medicines Agency (EMA) has recommended the approval of Bavarian Nordic’s Imvanex for the prevention of monkeypox disease. EMA’s backing of the vaccine is part of a raft of measures by the agency to tackle the pathogen and mitigate its impact.
Members of EMA’s Committee for Medicinal Products for Human Use recommended the approval of the vaccine late last week. Bavarian Nordic won approval for the product for the prevention of smallpox in the European Union in 2013. The vaccine contains a weakened form of a virus related to smallpox. As the monkeypox virus is similar to smallpox, the vaccine may be able to provide protection against both of the pathogens.
Bavarian Nordic has validated that hypothesis in non-human primates. Data from several animal studies showed the vaccine protects against monkeypox. EMA’s human medicines committee inferred from the data that Imvanex will prevent monkeypox disease in humans, although it still wants to see postmarket results to confirm efficacy in humans. Bavarian Nordic will run an observational study of Imvanex.
The committee backed the use of Imvanex for the prevention of monkeypox at a meeting that also saw it share opinions on other medicines. The actions included a call to restrict the use of Clovis Oncology’s Rubraca. After reviewing data showing patients lived longer after receiving chemotherapy, EMA advised against using Rubraca as a third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation.
EMA made its recommendations the day before the director-general of the World Health Organization declared the monkeypox outbreak a Public Health Emergency of International Concern. EMA followed up on the declaration of a public health emergency with a statement setting out its response to the crisis, the first it has faced since being given new powers to manage such situations.
Aspects of EMA’s recently gained powers that have previously only been used in relation to COVID-19 will now extend to monkeypox. EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products, which was created as part of the regulation that empowered the agency, will create a formal list of critical medicines for the monkeypox emergency.
Marketing authorization holders with medicines on the list will need to regularly update EMA about potential and actual shortages, available stocks and forecasts of supply and demand. Member states will share regular reports of the estimated demand for the medicines at the national level. The information will inform EU-level actions to mitigate potential or actual shortages of critical medicines.
EMA is also formally extending the remit of its Emergency Task Force to cover monkeypox. The task force has already been discussing available monkeypox treatments and vaccines and possible medical countermeasures. Now, EMA’s management board will formally review and approve the composition of the task force, taking into account the need for specific expertise related to the outbreak.
The role of the task force includes providing scientific advice on products relevant to the emergency, coordinating independent studies of medicinal products used against monkeypox and providing member states with recommendations about the use of unauthorized interventions against the virus. EMA sees the task force’s provision of advice about clinical trial protocols as particularly important. The task force is facilitating multinational clinical trials of the antiviral tecovirimat and the vaccine Imvanex.
Imvanex Statement, EMA Notice, More
WTO sides with EU in trade dispute, pushing Turkey to drop localization measures
The EU has hailed a “clear win” in its pharmaceutical trade dispute with Turkey. Based on the World Trade Organization’s (WTO) appeal arbitration award, Turkey will need to remove the localization and prioritization measures that triggered the case.
The case centered on a requirement for foreign producers of pharmaceuticals to move their production to Turkey to be eligible for reimbursement under social security schemes. Valdis Dombrovskis, executive vice-president and commissioner for trade in the EU, set out the implications of the WTO ruling. 
“Today's verdict is a clear win for the EU, because all claims were decided in the EU's favor. This is not only of economic importance for EU companies, but it also sends a strong signal discouraging other countries from continuing or pursuing similar discriminatory forced localization policies, which are incompatible with WTO rules,” Dombrovskis said.
Pharma trade group EFPIA welcomed the “swift completion” of the process, adding that the ruling “ensures non-discriminatory treatment of EU pharmaceutical exports to Turkey and continued access for Turkish patients to innovative and effective medicines, irrespective of the place of their manufacturing.”
Press Release, EFPIA Statement
Medicines for Europe warns against rationing energy available for drug production
Medicines for Europe has warned “strongly” against energy rationing for medicines production, stating that manufacturing “cannot simply be turned off for a few days and turned back on again.”
With gas supplies from Russia under threat, the EU recently published its “save gas for a safe winter” plan. The plan states, “Gas flow restrictions, rationing, and curtailment are taken as a last resort.” The potential for gas to be rationed triggered an immediate response from the off-patent drug trade group Medicines for Europe.
If energy is restricted, the trade group wants governments to maintain supply to drug production plants. “Even a temporary shutdown of production would demand a huge effort and a long time for our industry to resume production due to technical challenges related to temperature control, hygiene and impurities control and compliance with good manufacturing practice requirements,” the trade group wrote.
Press Release
UK competition watchdog fines Pfizer £63M over ‘abuse’ of market dominance
The UK Competition and Markets Authority (CMA) has fined Pfizer £63 million ($77 million) for its role in the charging of “unfairly high prices” for phenytoin sodium capsules for more than four years.
In 2016, CMA found Pfizer and Flynn broke competition law by debranding a drug, thereby excluding it from price regulation, and then charging prices between 780% and 1,600% higher than previously. As Pfizer and Flynn were the dominant UK suppliers of the drug, the healthcare service paid the inflated price for the anti-epilepsy medicine. Spending on the drug rose from £2 million to £50 million in a year.
Since then, Pfizer and Flynn have appealed to different bodies, culminating in a reassessment of the case by CMA. The competition watchdog found the companies abused their dominant positions in the market to overcharge the healthcare service for the medicine. CMA is fining Flynn £6.7 million for its role in the case.
Press Release
Other News:
EMA’s Emergency Task Force is reviewing data on the use of sabizabulin in the treatment of COVID-19. Veru Pharmaceuticals, the developer of the molecule, is yet to file for approval, but the task force is looking at the data to help member states evaluate whether to allow it to be used prior to authorization. The drug, originally developed for cancer, reduced risk of death in a recent COVID-19 trial. EMA Notice
EMA has endorsed a statement calling for international collaboration on the generation and use of real-world evidence for regulatory decision making. The International Coalition of Medicines Regulatory Authorities published the notice, in which members of the body pledged to cooperate on terminology harmonization, regulatory convergence, emerging health threats and transparency. EMA Notice


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