Tower Mains Weekly Newsletter
WHO and MPP announce agreement with NIH for COVID-19 health technologies
On 12th May, the World Health Organisation’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) announced it had finalised a licensing agreement with the United States National Institutes of Health (NIH) for the development of innovative therapeutics, early-stage vaccines, and diagnostic tools for COVID-19. The licenses, which are transparent, global, and non-exclusive, will allow manufacturers from around the world to work with MPP and C-TAP to make these technologies accessible to people living in low- and middle-income countries.
FDA approves Radicava ORS as ALS treatment
On 13th May, the US Food and Drug Administration (FDA) approved Radicava ORS oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version of Radicava, which was originally approved in 2017 as an intravenous (IV) infusion to treat ALS. The drug is self-administered, can be taken at home, and has the same dosing regimen as Radicava—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.
Gerrit Johan Schefferlie elected new Chair of EMA’s CVMP
On 13th May, the European Medicines Agency (EMA) announced its Committee for Veterinary Medicinal Products (CVMP) had elected Gerrit Johan Schefferlie as its new Chair for the next three years. Schefferlie has been a member of the CVMP since 2007 and its Vice-chair since July 2019. He is a biologist by training and has been a Senior Regulatory Project Leader at the Dutch Medicines Evaluation Board since 2007. With experience in toxicological and consumer risk assessment of residues of veterinary drugs in food of animal origin, he has collaborated as an expert for the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), the European Food Safety Authority (EFSA) and the Joint WHO/FAO Expert Committee on Food Additives (JECFA). The CVMP will elect a new Vice-chair at its June 2022 meeting.
FDA approves dual-targeted treatment for Type 2 diabetes
On 13th May, the FDA approved Mounjaro injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. The drug was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies. Mounjaro has not been studied in patients with a history of pancreatitis, and it is not indicated for use in patients with type 1 diabetes.
EMA issues highlights from the latest CVMP meeting
On 13th May, the EMA issued meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) held on the 10th-12th May 2022.
FDA strives to engage stakeholders on key considerations for a drug quality management maturity programme
On 17th May, the FDA announced it had published a white paper to incentivise drug manufacturers to invest in a quality management maturity (QMM) programme. The paper describes key considerations for measuring and rating a drug manufacturer’s quality management maturity, and their ability to deliver high-quality drugs reliably and without disruption. A QMM rating system could inform regulators and drug purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. The FDA will host a two-day workshop on the 24th and 25th of May for stakeholders to discuss their thoughts, perspectives and feedback on the development of a QMM programme.
ICMRA: How COVID-19 vaccines are regulated for safety and effectiveness
On 17th May, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organisation (WHO) released a joint statement aimed to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines and to reassure medical staff about the safety of COVID-19 vaccines. ICMRA and WHO also highlight the measures put in place nationally and globally to continuously monitor the safety of COVID-19 vaccines that are used in countries worldwide.
MHRA approves faricimab through international work-sharing initiative
On 17th May, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it had approved faricimab, a new medicine for people with the progressive eye diseases wet age-related macular degeneration (wet AMD) and visual impairment due to diabetic macular oedema (DMO), through the Access Consortium ‘New Active Substance Work Sharing Initiative’ – a collaboration of international regulatory authorities. The treatment has been shown to be effective in improving vision or reducing vision loss in these patient groups but has the added benefit in that it can be given less frequently in selected patients than other medicines currently available.
MHRA publishes May’s Drug Safety Update newsletter
On 17th May, the MHRA issued the May edition of its Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines.
Issue Number: WN00061