Tower Mains Weekly Newsletter
EMA recommends authorisation of Evusheld for treatment of COVID-19
On 24th March, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) had recommended granting a marketing authorisation for Evusheld, developed by AstraZeneca AB, for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus. In reaching its conclusion, the CHMP evaluated data from a study in over 5,000 people showing that Evusheld, given as two injections of 150 mg tixagevimab and 150 mg cilgavimab, reduced the risk of COVID-19 infection by 77%, with the duration of protection from the virus estimated to be at least six months.
European Commission publishes record of 98th meeting of the Pharmaceutical Committee
On 24th March, the European Commission published the summary record of the 98th meeting of the Pharmaceutical Committee, held on the 20th of January 2022.
FDA limits use of Sotrovimab to treat COVID-19 in some regions
On 25th March, the US Food and Drug Administration (FDA) updated the sotrovimab emergency use authorisation to limit its use to treat COVID-19 in some regions due to the BA.2 Omicron sub-variant. New data included in the health care provider fact sheet shows that the authorised dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Therefore, it may not be administered for treatment of COVID-19 in the below regions under the emergency use authorisation until further notice by the agency:
- Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (HHS Region 1)
- New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2)
New gene therapy to treat adult patients with multiple myeloma
On 25th March, the EMA recommended a conditional marketing authorisation in the European Union (EU) for Carvykti for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment. Ciltacabtagene autoleucel, the active substance of Carvykti, is a chimeric antigen receptor (CAR)-T cell medicine. It is an advanced therapy for cancer that is based on collecting and modifying patient’s immune T-cells to create a patient personalised treatment that is infused back. The treatment was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs.
FDA publishes guidance on the use of human blood and blood components
On 25th March, the FDA published final guidance providing specific labelling instructions for the administration and use of blood and blood components intended for transfusion. The agency believes that the December 2021 Circular will assist in complying with labelling requirements under 21 CFR 606.122 which specify that a circular of information must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the circular of information. The guidance supersedes the guidance of the same title updated in December 2017.
MHRA: How to get scientific advice about your licence application
On 25th March, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the contact information on its guidance on how to get scientific advice about your licence application from MHRA, including submitting a request and fees.
MHRA updates list of herbal medicines granted a traditional herbal registration
On 25th March, the MHRA updated the list of herbal medicines currently holding a traditional herbal registration (THR).
AstraZeneca aims to transform oncology treatment
On 28th March, AstraZeneca announced it will present new data underscoring the breadth of its early oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting on the 8th to 13th April 2022. Data from 60 presentations, including five oral and three mini-oral presentations, will feature the company’s next surge of potential cancer medicines spanning its immuno-oncology (IO), DNA Damage Response (DDR), and Antibody Drug Conjugate (ADC) scientific platforms. This includes data shared from three potential new medicines that illustrate the company’s innovative approach to designing molecules that address key challenges in treating cancer.
Pharma companies unite to form AI-based start-up
AION Labs – comprised of AstraZeneca, Merck, Pfizer, Teva, and the Israel Biotech Fund – and German independent research institute BioMed X announced its third global call for applications to form a new start-up company focused on using AI to design and optimise antibodies for targeted therapies. The announcement aims to entice innovative thinkers to find ways to develop solutions to common pharma challenges by analysing existing antibody therapies to make new efficient and effective therapies using AI.
FDA authorises second booster dose of COVID-19 vaccines for older immunocompromised individuals
On 29th March, the FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorised a single booster dose for certain immunocompromised individuals following the completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalisation, and death.
EMA starts rolling review of COVID-19 Vaccine HIPRA
On 29th March, the EMA’s CHMP announced it had started a rolling review of HIPRA (PHH-1V) COVID-19 vaccine. This protein-based vaccine is being developed by HIPRA Human Health S.L.U. as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine. Preliminary results suggest that the immune response with the vaccine may be effective against SARS-CoV-2, including variants of concern such as Omicron.
Issue Number: WN00054