Tower Mains Weekly Newsletter

Industry Updates

ICMRA holds high-level meeting on global health emergencies and regulatory approaches

​​​​ On 1st and 2nd December, the International Coalition of Medicines Regulatory Authorities (ICMRA) held a high-level meeting to discuss regulatory challenges, including those faced during the ongoing COVID-19 pandemic. Participants from the 24 members and 13 associated members and experts from the World Health Organisation (WHO) and the European Commission also discussed the path towards regulatory alignment on the global response to the Omicron variant. One of the goals of the meeting was to exchange information on regulatory approaches to the COVID-19 response, draw lessons learned and identify future priorities and opportunities to strengthen regulatory preparedness for future public health emergencies.

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EMA starts rolling review of Valneva’s COVID-19 vaccine

​​​​On 2nd December, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) had started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease. EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.

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MHRA approves Xevudy as COVID-19 treatment

​​​​On 2nd December, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Xevudy had been approved as a COVID-19 treatment after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate infection who are at an increased risk of developing severe disease. This follows a rigorous review of its safety, quality, and effectiveness by the agency and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the second monoclonal antibody therapeutic to be approved following Ronapreve. Information for healthcare professionals and the public about Xevudy is available here.

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MHRA updates information for healthcare professionals and the public about the Pfizer/BioNTech vaccine

​​​​On 2nd December, the MHRA updated the Conditional Marketing Authorisation for the Comirnaty COVID-19 vaccine. Changes have been made to the SmPC – section 9 and section 10.

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ICMRA and WHO issue report on the flexibilities used by regulators to respond to the COVID-19 pandemic

On 3rd December, ICMRA and the WHO issued a report on the review of the practices applied by regulatory authorities worldwide to respond to the challenges faced during the COVID-19 pandemic. The report was developed following a review exercise conducted by ICMRA members and WHO experts, and a series of discussions on strategic issues and regulatory flexibilities to enhance the efficiency and effectiveness of regulatory decision-making during the current pandemic.

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FDA expands authorisation of two monoclonal antibodies for treatment and prevention of COVID-19

​​​​On 3rd December, the US Food and Drug Administration (FDA) revised the emergency use authorisation (EUA) of bamlanivimab and etesevimab for the treatment and post-exposure prevention of COVID-19 in all paediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalisation or death.

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MHRA publishes time-based performance measures for November

​​​​On 3rd December, the MHRA issued updated statistics on the expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.

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EMA recommends approval for use of RoActemra in adults with severe COVID-19

​​​​On 3rd December, the EMA announced its human medicines committee (CHMP) had recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation. The medicine, marketed by Roche Registration GmbH, is already approved in the EU for treating the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, and cytokine release syndrome (CRS).

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EMA and ECDC publish recommendations and advice on heterologous vaccination courses against COVID-19

​​​​On 7th December, the EMA and European Centre for Disease Prevention and Control (ECDC) published their recommendations and advice on heterologous vaccination courses against COVID-19. To provide scientific grounds and further flexibility to vaccination schemes, the EMA and ECDC – in collaboration with EU experts in EMA’s COVID-ETF group – have reviewed the available evidence, and provided technical recommendations and advice on heterologous vaccination against COVID-19, either in the primary course or as a booster. Evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine in a primary or booster regimen.

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FDA issues draft guidance for sponsor-investigators developing individualised investigational ASO drug products

On 7th December, the FDA issued draft guidance intended for sponsor-investigators developing individualised investigational antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening (SDLT) genetic disease. The draft guidance describes important clinical considerations for investigational new drug application (IND) submissions to support initial and continued administration, dosing, and clinical monitoring of an individual who is eligible to receive an individualised investigational ASO drug.

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FDA issues draft guidance on investigational new drug application submissions

On 7th December, the FDA issued draft guidance to provide recommendations regarding the chemistry, manufacturing, and controls (CMC) information that should be provided in an investigational new drug application (IND) submitted by a sponsor-investigator developing an individualised ASO drug product for an SDLT disease caused by a unique genetic variant where only a small number of individuals are prospectively identified.

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Issue Number: WN00040

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