Tower Mains Weekly Newsletter
FDA approves an abbreviated new drug application for vancomycin hydrochloride for injection
On 18th November, the US Food and Drug Administration (FDA) approved an abbreviated new drug application for vancomycin hydrochloride for injection, indicated to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. The side effects of vancomycin hydrochloride for injection include diarrhoea, hypotension (low blood pressure), acute kidney injury, and ototoxicity (damage to the ear).
European regulators publish their vision of enabling the use of real-world evidence (RWE) and establishing its value
European regulators, including the EMA’s Executive Director and its Head of Data Analytics, have published their vision of enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation, and supervision of medicines in Europe by 2025. The authors emphasise that delivering this vision, anchored in the Network Strategy to 2025, will support the development and use of better medicines for patients. The article explains plans to establish methods and standards for high-quality collection and use of RWE, in cooperation with stakeholders including patients, healthcare professionals, industry, regulatory and public health agencies, and academia.
FDA approves first drug to improve growth in children with common form of dwarfism
On 19th November, the FDA approved the Voxzogo injection to improve growth in children five years of age and older with achondroplasia and open growth plates, meaning these children still have the potential to grow. Voxzogo’s safety and efficacy in improving growth were evaluated in a year-long, double-blind, placebo-controlled, phase 3 study in participants five years and older with achondroplasia who have open epiphyses. The FDA approved it under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint.
EMA announces webinar SMEs and academia on the EU Clinical Trials Regulation and the CTIS
EMA announced it is organising an online seminar to inform small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials on how to prepare for the main changes brought by the EU Clinical Trials Regulation and the Clinical Trials Information System (CTIS), which become applicable as on 31st January 2022. This will take place on Monday, 29th November from 9am until 1:30pm (CET).
EMA reports a significant decrease in sales of antimicrobials for use in animals
The annual report on the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) – published on the 23rd of November by the EMA – shows that European countries have substantially reduced the use of antimicrobials in animals. According to data from the twenty-five countries that provided input for the full 2011-2020 period, overall sales of veterinary antimicrobials in European countries were 43% lower in 2020 than in 2011. The ESVAC report is published annually and is used as a reference source of information for scientists, veterinarians and other health professionals, risk assessors, and policymakers in the EU Member States on the topic of antimicrobial resistance. Under Regulation (EU) 2019/6, reporting of sales and use data for antimicrobials in animals will become a legal obligation for EU Member States and the EMA. The new requirements will apply to data from 2023 onwards.
FDA approves treatment for common type of post-transplant infection that is resistant to other drugs
On 23rd November, the FDA approved Livtencity as the first drug for treating adults and paediatric patients (12 years of age and older and weighing at least thirty-five kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity works by preventing the activity of the human cytomegalovirus enzyme pUL97, thus blocking virus replication. Its safety and efficacy were evaluated in a Phase 3, multicentre, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir
WHO’s Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) holds first meeting
On 24th November, the WHO´s Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) held its first meeting. SAGO is composed of experts acting in a personal capacity and will collaborate with additional experts from various technical areas as needed, and in its capacity as an advisory body to the World Health Organisation (WHO), it will have the following functions:
- Advise on the development of a WHO global framework to define and guide studies into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential.
- Advise on prioritising studies and field investigations into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential, per the WHO global framework.
- Provide information and views to assist the WHO Secretariat in the development of a detailed work plan of the SAGO.
The meeting was procedural and included the appointment of the Chair (Dr Marietjie Venter from South Africa) and Vice-Chair (Dr Jean-Claude Manuguerra from France).
MHRA issues guidance on cleaning and decontamination of medical devices used in cataract removal
On 24th November, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance to minimise the risks associated with inadequate or improper cleaning and decontamination of phacoemulsification (phaco) handpieces. This follows concerns regarding particulates found in the eye during or following surgery, with the potential to lead to post-operative infection. During 2020 the MHRA worked with leading manufacturers of phacoemulsification handpieces to ensure that the cleaning and decontamination instructions supplied with the devices were amended and updated to meet the latest regulatory requirements for safety and performance for CE marked devices.
EMA evaluating application for marketing authorisation for Xevudy for COVID-19
On 18th November, the European Medicines Agency (EMA) announced it had started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy. The applicant is GlaxoSmithKline Trading Services Limited, who developed the medicine together with Vir Biotechnology. It is intended for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19. EMA will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months, depending on whether the data submitted are sufficiently robust and whether further information is needed to support the evaluation
FDA expands eligibility for COVID-19 vaccine boosters
On 19th November, the US Food and Drug Administration (FDA) amended the emergency use authorisations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorising the use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorised or approved COVID-19 vaccine. The action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.
EMA starts review of Paxlovid for treating patients with COVID-19
On 19th November, the EMA announced it is reviewing currently available data on the use of Paxlovid, an oral treatment for COVID-19 developed by Pfizer. EMA’s human medicines committee (CHMP) will look at data from a study comparing the effect of Paxlovid with that of a placebo in non-hospitalised patients with mild to moderate COVID-19 who were at elevated risk of progressing to severe disease. The preliminary results show that Paxlovid reduced the risk of hospitalisation or death compared with placebo when treatment was given within 3 or 5 days of the start of symptoms. The CHMP will also review data on the medicine’s quality and safety.
EMA issues advice on use of Lagevrio for the treatment of COVID-19
On 19th November, the EMA announced its human medicines committee (CHMP) has issued advice on the use of Lagevrio for the treatment of COVID-19. The medicine, which is currently not authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19. Lagevrio should be administered as soon as possible after a diagnosis of COVID-19 and within 5 days of the start of symptoms.
EMA evaluating data on booster dose of Janssen COVID-19 vaccine
On 22nd November, the EMA announced it had started evaluating an application for the use of a booster dose of Janssen COVID-19 vaccine to be given at least two months after the first dose to people aged 18 years and older. EMA’s CHMP will conduct an accelerated assessment of data given by the company that markets the vaccine. These data include results from more than 14,000 adults who received a second dose of the vaccine or placebo two months after the first dose. The CHMP will recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within weeks, unless supplementary information is needed, and will be communicated by EMA.
Issue Number: WN00038