Approvals

Health Canada approves Biogen’s Zurzuvae for PPD treatment

Biogen has received a notice of compliance (NOC) from Health Canada for Zurzuvae (zuranolone), a neuroactive steroid (NAS), as a treatment for moderate or severe postpartum depression (PPD) in women.

EC approves Roche’s Gazyva to treat active lupus nephritis

Roche has received approval from the European Commission (EC) for its humanised monoclonal antibody Gazyva/Gazyvaro (obinutuzumab) along with mycophenolate mofetil (MMF), for adults with active Class III or IV lupus nephritis, with or without concomitant Class V.

FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL

Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of Jaypirca (pirtobrutinib) tablets, in 100mg and 50mg doses, to treat adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

Lotus submits NDA for VIZZ in South Korea to treat presbyopia

Lotus Pharmaceutical has submitted a new drug application (NDA) to the Ministry of Food and Drug Safety (MFDS) for VIZZ (aceclidine ophthalmic solution) 1.44%, seeking approval in South Korea for presbyopia treatment in adults.

Eisai seeks PMDA approval for subcutaneous Leqembi in Japan

Eisai has submitted a new drug application seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) formulation (SC-AI) for early Alzheimer’s disease.

US FDA approves Lupin’s Armlupeg injection

Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe for subcutaneous use as a biosimilar to Neulasta (pegfilgrastim).

IASO Bio gains Hong Kong approval for Fucaso application

IASO Biotechnology has received the Hong Kong Department of Health’s approval for its biologics licence application (BLA) for the fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, Fucaso (Equecabtagene Autoleucel), for adults with relapsed or refractory multiple myeloma (R/R MM).

MHRA approves Roche Products’ inavolisib for breast cancer

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Roche Products’ inavolisib (Itovebi) to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

USPTO grants patent to Genprex’s Reqorsa gene therapy

The US Patent and Trademark Office (USPTO) has granted a patent to Genprex for the use of its Reqorsa gene therapy in conjunction with programmed death-ligand 1 (PD-L1) antibodies such as Tecentriq (atezolizumab) for cancer treatment.