Drug approvals are critical to the drug discovery industry, ensuring innovation thrives while the public remain safe from the risks and benefits associated with new drugs. Organisations responsible for these approvals include the US Food and Drug Administration (FDA), the European Medical Agency (EMA), the Scottish Medicines Consortium (SMC), the Medicines and Healthcare products Regulatory Agency (MHRA), and the National Medical Products Administration (NMPA) – formerly the China Food and Drug Administration or CFDA – to name a few.
Though standards vary internationally, public health and safety remains at the forefront of this regulatory system. Here, DDW’s Megan Thomas has highlighted five approvals from 2022 which will enable breakthroughs, clinical trial commencement and drug development in the future.
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.
Angelini Pharma has announced that cenobamate, an oral anti-seizure medicine (ASM), is now available for use within NHS Scotland as a treatment for eligible adults with uncontrolled focal epilepsy. The SMC has accepted cenobamate for restricted use in adults with drug-resistant epilepsy as a second-line adjunctive ASM, after failure of the first adjunctive ASM
The National Institute for Health and Care Excellence (NICE) in the UK has issued a Final Appraisal Document (FAD) recommending AstraZeneca’s Forxiga (dapagliflozin) within its marketing authorisation for the treatment of adults with chronic kidney disease (CKD).
The FDA has approved the Biologics License Application (BLA) for Moderna’s Spikevax, an mRNA vaccine for prevention of Covid-19 in individuals 18 years of age and older.
The FDA has cleared investigational new drug (IND) applications for MRx0005 and MRx0029, two 4D Pharma Live Biotherapeutics (LBPs). The company expects to initiate a first-in-human Phase I clinical trial in people with Parkinson’s disease in mid-2022.