Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- On 5th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Click to view source
- On 6th December, guidance was updated on how to register medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Click to view source
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
On 5th December, the US Food and Drug Administration (FDA) issued final guidance intended to provide internationally harmonised guidance on the use of selective safety data collection that may be applied in specific pre-approval or post-approval late-stage clinical trials. By tailoring the method and streamlining the approach to safety data collection, it may be possible to conduct clinical trials with greater efficiency and may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up.
Industry Updates
EMA recommends the withdrawal of pholcodine medicines from EU market
On 2nd December, the European Medicines Agency (EMA) announced its safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive cough and for the treatment of symptoms of cold and flu, and has recommended the withdrawal of the EU marketing authorisations for these medicines. During the review, the PRAC evaluated all available evidence which showed that the use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction to NMBAs. As it was not possible to identify effective measures to minimise this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter.
Registration opens for FDA’s Rare Disease Day virtual event
On 5th December, registration opened for the FDA’s Rare Disease Day virtual event which will be held on Monday, 27th February 2023. This year’s theme is “Intersections with Rare Diseases – A patient-focused event” which will explore a range of topics related to rare diseases. Participants will have the opportunity to:
- Hear from the FDA on initiatives to advance medical product development for rare diseases
- Engage with the FDA to provide perspectives
- Understand considerations and challenges associated with clinical trials in small populations
- Hear from medical students on rare disease education for medical professionals
Novartis Pluvicto™ becomes the first PSMA-targeted therapy to present survival benefit in mCRPC
On 5th December, Novartis announced its Pluvicto™, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, has shown significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Novartis’ open-label, multi-centre, 1:1 randomised phase 3 PSMAfore trial with Pluvicto™ evaluated 469 participants and met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA-positive mCRPC patients who have been treated with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.
FDA issues updated safety communication on the use of Endologix AFX endovascular grafts
On 6th December, the FDA issued an updated safety communication on the use of Endologix AFX endovascular grafts, which includes information about new labelling and a required post-market study for the AFX2 Endovascular AAA System (AFX2) to better inform patients and healthcare providers of the risk of Type III endoleaks. The FDA continues to recommend healthcare providers consider using available alternative treatment options for patients with abdominal aortic aneurysms (AAA) rather than the AFX2 device.
Comirnaty COVID-19 vaccine authorised for use in infants and children aged 6 months to 4 years in the UK
On 6th December, the MHRA granted authorisation for a new presentation of the Pfizer/BioNTech COVID-19 vaccine, Comirnaty, for use in infants and children aged 6 months to 4 years. This presentation is specially designed for this new age group and given at a lower dose compared to that used in individuals aged 5 to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose given at least eight weeks after the second dose. It will be for the Joint Committee on Vaccination and Immunisation (JCVI) to determine if the vaccine will be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme.
Bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination in the EU
On 6th December, the EMA announced its Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for primary vaccination. The data suggests that primary vaccination with these adapted bivalent vaccines should give rise to a broad immune response in people who have not yet been exposed to, or vaccinated against, SARS-CoV-2.
Issue Number: WN00090
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