Tower Mains Weekly Newsletter
Regulatory Updates
European Commission proposes pharmaceuticals reform for more accessible, affordable, and innovative medicines
On 26th April, the European Commission proposed to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years – to make medicines more available, accessible, and affordable across the EU. It will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry while promoting higher environmental standards. The proposed revision consists of two legislative proposals:
- A new Directive, amending and replacing Directive 2001/83/EC and incorporating and amending relevant parts of the paediatric Regulation (EC) 1901/2006
- A new Regulation, amending and replacing Regulation (EC) No 726/2004, incorporating and amending the orphan Regulation 141/2000/EC, and incorporating and amending relevant parts of the paediatric Regulation (EC) No 1901/2006.
Under this proposed revision, Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation 141/2000/EC and Regulation (EC) 1901 /2006 would be repealed and replaced by the proposed new Directive and Regulation above. An FAQ of the revision was published on the Commission’s website.
MHRA guidance updates
- Adrenaline Auto-Injectors (AAIs) safety campaign: On 24th April, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance to help better understand the importance of AAIs as a potentially life-saving medicine. AAIs are licensed medicinal products that deliver adrenaline using an auto-injector device for the emergency treatment of anaphylaxis, a life-threatening severe allergic reaction. Click to view source
- Medical devices: guidance for manufacturers on vigilance. On 26th April, the MHRA updated MORE Platform information in its guidance for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Click to view source
FDA guidance updates
- Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment: On 19th April, the FDA issued draft guidance to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Click to view source
- Registering with CVM’s electronic submission system. On 19th April, the FDA issued final guidance on general standards which should be used to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS). Click to view source
Industry Updates
FDA authorises Bateman Bottle Breast Implant Removal System
On 20th April, the FDA authorised for marketing the Bateman Bottle Breast Implant Removal System (BIRS), a single-patient, single-use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. This device is not intended for en bloc removal and is not intended to remove residual silicone or be applied directly to tissue.
Medigene reveals pivotal blood cancer therapy data
On 24th April, Medigene AG, an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumours, reported final Phase I dose escalation results from the first-in-human study of MDG1011, a therapy which aims to improve outcomes for in patients with high-risk blood cancers.
MHRA Chair Stephen Lightfoot to stand down
On 24th April, the MHRA announced its Chair, Stephen Lightfoot, has decided to stand down in July 2023 after almost 8 years as a Board Member. This is in line with his view that non-Executives should not remain on any Board for more than 8 years to maintain their independent thought and objectivity. It will also enable him to focus more time on his other role as Chair of the NHS Sussex Integrated Care Board and his grandchildren.
First orally administered fecal microbiota product for the prevention of recurrence of clostridioides difficile infection approved in US
On 26th April, the FDA approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI. Its effectiveness was evaluated in the randomised, placebo-controlled clinical study in which 89 participants received the product and 93 participants received a placebo. The product contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals.
MHRA safety review of isotretinoin concludes
On 26th April, the MHRA published a report following a review of the safety of isotretinoin. Isotretinoin is an effective last-line treatment for severe acne. However, patients and members of the public have raised concerns about suspected side effects associated with isotretinoin, including mental health and sexual side effects that sometimes continue after treatment with isotretinoin has been stopped. Considering these concerns, the Commission on Human Medicines (CHM) formed the Isotretinoin Expert Working Group and asked it to look at the overall safety of the medicine. Following the in-depth safety review, the CHM agreed on several recommendations to strengthen the safe use of the treatment. These recommendations will be taken forward by the MHRA.
EMA CHMP’s latest meeting highlights
On 26th April, the European Medicines Agency (EMA) issued highlights from its Committee for Medicinal Products for Human Use (CHMP), held on the 24th – 26th of April 2023. At this monthly meeting, the committee discussed medicines recommended for approval, the Statement on the Interchangeability of Biosimilar medicines, and COVID-19 updates.
MHRA publishes drug safety updates
- Nitrofurantoin: a reminder of the risks of pulmonary and hepatic adverse drug reactions. On 26th April, the MHRA issued a reminder to healthcare professionals prescribing nitrofurantoin, that they should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation. Click to view source
- Janus kinase inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections, and increased mortality. On 26th April, the MHRA published advice to healthcare professionals on new risk minimisation measures for JAK inhibitors used to treat chronic inflammatory disorders, consistent with the measures introduced for tofacitinib (Xeljanz) in 2020 and 2021. When used for chronic inflammatory disorders, this advice affects abrocitinib (Cibinqo▼), baricitinib (Olumiant), upadacitinib (Rinvoq▼), and filgotinib (Jyseleca▼). Click to view source
European Commission issues FAQ on stepping up EU actions to combat AMR in a One Health approach
On 26th April, the European Commission published a FAQ on stepping up EU actions to combat antimicrobial resistance (AMR) in a One Health approach. The One Health approach is based on the principle that human, animal, and environmental health are intrinsically linked and in order to fight against AMR human, animal and environmental concerns must be addressed comprehensively.
First vaccine to protect older adults from respiratory syncytial virus infection recommended
On 27th April, the EMA announced it has recommended a marketing authorisation for Arexvy (recombinant, adjuvanted) in the EU. It is the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). Arexvy was evaluated under EMA’s accelerated assessment mechanism because prevention of RSV infection in the elderly population is of public health interest.
Issue Number: WN00109
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