Tower Mains Weekly Newsletter
FDA authorises first COVID-19 diagnostic test using breath samples
On 14th April, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The InspectIR COVID-19 Breathalyser uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the presence of VOC markers of SARS-CoV-2 is detected, a presumptive positive test result is returned and should be confirmed with a molecular test. The test is to be performed by a qualified, trained operator under the supervision of a health care provider.
MHRA approves the Moderna COVID-19 vaccine for use in 6- to 11-year-olds
On 14th April, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the approval of an update to the current UK approval of the Moderna COVID-19 Vaccine to allow use in 6- to 11-year-olds.
EAMS scientific opinion issued for risankizumab in the treatment of active Crohn’s disease
On 14th April, the MHRA announced that an early access to medicines scheme (EAMS) scientific opinion has been issued to AbbVie Ltd for risankizumab in the treatment of moderately to severely active Crohn’s disease in adult patients who did not respond or were contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab and adolescent patients aged 16 to 17 years who did not respond or were contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies.
FDA announces draft guidance for animal drug sponsors
On 19th April, the FDA announced a draft revision of the guidance “The Use of Published Literature in Support of New Animal Drug Approvals,” which will be open for public comment on the 20th of April 2022. The document provides guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application, an abbreviated new animal drug application, or a conditionally approved new animal drug application. This draft guidance expands upon the original guidance #106 – published in 2000 – by considering multiple uses of the scientific literature to support approval of a new animal drug.
EMA issues highlights from the latest CVMP meeting
On 19th April, the European Medicines Agency (EMA) issued highlights from its Committee for Veterinary Medicinal Products (CVMP) held on the 11th to 13th of April 2022.
New study suggests pregabalin may slightly increase the risk of major congenital malformations during pregnancy
On 19th April, the MHRA published findings of a safety study on the risks of using pregabalin (Lyrica) during pregnancy. The observational study of more than 2,700 pregnancies exposed to pregabalin showed use in the first trimester to be associated with a slightly increased risk of major congenital malformations compared with exposure to no antiepileptic drugs or lamotrigine or duloxetine. It is recommended to continue to avoid the use of pregabalin during pregnancy unless clearly necessary and only if the benefit to the patient outweighs the potential risk to the foetus.
MHRA publishes April’s Drug Safety Update newsletter
On 19th April, the MHRA issued the April edition of its Drug Safety Update newsletter from the agency and its independent advisor the Commission on Human Medicines.
FDA grants Priority Review to Enhertu for adult patients with unresectable or metastatic NSCLC
On 19th April, it was announced that AstraZeneca and Daiichi Sankyo had received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu, a HER2-directed antibody-drug conjugate (ADC) being jointly developed by the two organisations. It has also been granted Priority Review by the FDA. If approved, Enhertu will provide patients with a much-needed targeted therapy option for those with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation.
Issue Number: WN00057