FDA & EMA
1. On April 4, InflaRx announced that the vilobelimab (brand name: Gohibic) was approved by the FDA for marketing to treat critically ill patients with COVID-19 receiving mechanical ventilation. Vilobelimab is considered the first anti-C5a monoclonal antibody introduced into clinical development. At present, Vilobelimab is being developed for several indications other than COVID-19, including hidradenitis suppurativa, ANCA-associated vasculitis, and pyoderma gangrenosum.
2. On April 17, AbbVie announced that the FDA approved to expand the indications of atogepant (brand name: Quilipta) for the preventive therapy of chronic migraine. It makes atogepant the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention of episodic and chronic migraine. Chronic migraine is a neurological disorder that affects the ability to work and live. Patients have headaches for no less than 15 days per month for consecutive 3 months and present the features of chronic migraine at least 8 days per month.
3. On April 26, Seres Therapeutics announced that the FDA approved SER-109 (brand name: Vowst) for marketing to prevent recurrent clostridium difficile infection (rCDI), including the first recurrence after antibacterial therapy. SER-109 is an oral microflora therapy based on bacterial spores purified from healthy human feces and containing approximately 50 species of bacteria on average. It can inhibit the growth of clostridium difficile by reconstituting the intestinal flora.
4. On April 27, Otsuka Pharmaceutical and Lundbeck Pharmaceutical co-announced that FDA approved the marketing of ready-to-use aripiprazole 2-month long-acting injectable (brand name: ABILIFY ASIMTUFII) for the use of single-drug maintenance therapy in adult patients with schizophrenia as well as bipolar I disorder. It is the first 2-month long-acting antipsychotic approved by the FDA targeting two indications simultaneously.
Orphan Drug Designation
5. On April 3, HuidaGene announced that the HG004 injection obtained orphan drug designation granted by the FDA for treating inherited retinal diseases caused by RPE65 mutations. HG004 injection is an understudied drug for a novel ophthalmic gene therapy designed to treat RPE65 mutations-associated retinopathy. It utilizes a recombinant adeno-associated viral vector to deliver a functional human RPE65 gene to the retina, thus restoring, treating, and preventing blindness in children and adults with RPE65 mutation-associated IRD.
6. On April 3, Abbisko announced that ABSK012 was granted orphan drug designation by the FDA for the treatment of soft tissue sarcomas (STS). ABSK012 is a next-generation anti-FGFR4 oral inhibitor with good bioavailability and high selectivity. Previous studies have shown that ABSK012 is highly potent against wild-type and mutant FGFR4.
7. On April 20, BioNova Pharmaceuticals announced that BN104 was granted orphan drug designation by the FDA for treating acute myeloid leukemia (AML). BN104 is a novel and highly potent small molecule oral menin inhibitor developed by BioNova Pharmaceuticals. It is designed for treating patients with relapsed or refractory acute leukemia with MLL gene rearrangements and NPM1 gene mutations.
NMPA
8. On April 6, the NMPA official website revealed that Yifan Pharmaceutical's class 5.1 new drug, BDDE crosslinked sodium hyaluronate injection, was approved for marketing in the treatment of knee osteoarthritis. BDDE crosslinked sodium hyaluronate, developed by LGChem, is a single-dose preparation. In December 2017, Yifan Pharmaceutical entered into a product licensing agreement with LGChem, receiving the exclusive interest of HyruanONE in China and Australia and taking charge of the clinical research required for product registration.
9. On April 4, InflaRx announced that the vilobelimab (brand name: Gohibic) was approved by the FDA for marketin...
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