Pharmaceutical Companies Under Scrutiny: Biogen/Eisai, Sanofi, Ionis, and Others Face FDA Review
FDA Decisions Approach on Various Drugs for Different Diseases
The Food and Drug Administration (FDA) is set to make several decisions on proposed drugs for various diseases in the coming weeks. Here's a roundup of the upcoming decisions and their potential impact.
Bronchiectasis
The FDA has already approved Brinsupri, a dipeptidyl peptidase 1 inhibitor, for the treatment of bronchiectasis patients. If approved, Brinsupri could become the first drug specifically designed for this condition [2].
Fibromyalgia
Tonmya, a sublingual formulation of cyclobenzaprine hydrochloride, is proposed for the management of fibromyalgia. If approved, Tonmya would be the first therapy for fibromyalgia in more than 15 years [2].
Recurrent Respiratory Papillomatosis
Papzimeos, an adenoviral vector-based immunotherapy, is proposed for the treatment of recurrent respiratory papillomatosis. If approved, Papzimeos would be the first treatment for this rare and lifelong neoplastic lung disease [2].
Wet Age-Related Macular Degeneration
Outlook Therapeutics' ONS-5010 is being proposed for the treatment of wet age-related macular degeneration. If approved, Outlook plans to market ONS-5010 under the brand name Lytenava [2].
Alzheimer's Disease, Friedrich's Ataxia, Hereditary Angioedema, Immune Thrombocytopenia
No recent FDA approvals or expected decision dates were found for new drugs targeting these conditions in the provided search results up to August 2025 [1][2][3][4][5]. For updates or specifics on ongoing reviews, consult FDA announcements or specialized pipeline reports.
Hereditary Angioedema
Ionis Pharmaceuticals' proposal to use the RNA-targeting therapy donidalorsen to prevent attacks in patients with hereditary angioedema (HAE) will be decided by Aug 21. If approved, monthly treatment with donidalorsen could potentially cut HAE attacks by 81% versus placebo [1].
Immune Thrombocytopenia
Sanofi's application for BTK inhibitor rilzabrutinib for the treatment of immune thrombocytopenia (ITP) is under review by the FDA. If approved, rilzabrutinib could help address ITP by tamping down several inflammatory and immune pathways [1].
Fibromyalgia and Wet Age-Related Macular Degeneration
The FDA will release its decision on Aug 15 for Tonix Pharmaceuticals' non-opioid candidate TNX-102 SL for the management of fibromyalgia. The FDA is scheduled to release its decision on Outlook Therapeutics' ONS-5010 for the treatment of wet age-related macular degeneration on Aug. 27 [1].
Bronchiectasis
The FDA is expected to decide on Insmed's proposal for brensocatib, an oral DPP1 blocker for the treatment of bronchiectasis, by Aug 12. If approved, brensocatib could become the first drug for bronchiectasis [1].
Recurrent Respiratory Papillomatosis
Precigen is advancing PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). If approved, PRGN-2012 will be the first treatment for RRP [1].
Alzheimer's Disease
Biogen and Eisai's proposed subcutaneous maintenance formulation of their anti-amyloid Alzheimer's therapy Leqembi is under review by the FDA. A verdict is due on Aug. 31 [1].
References: [1] FDA Drugs @ FDA: Drug Information Portal. (n.d.). Retrieved August 1, 2023, from https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm [2] FDA approves Brinsupri for bronchiectasis, Tonmya for fibromyalgia, and Papzimeos for RRP. (2025, August 1). Retrieved August 1, 2023, from https://www.fiercepharma.com/pharma/fda-approves-brinsupri-for-bronchiectasis-tonmya-for-fibromyalgia-and-papzimeos-for-rrp
Read also:
- Transmissible Infections and Parasites Found in Untreated Berries
- Rise in Legionnaires' disease cases in NYC reaches 90, prompting city health officials to propose strict cooling tower regulations
- Actor Boris Shcherbakov admitted to hospital following a fall incident
- Satellite Internet Services by Starlink: Ideal for Campers and Van Dwellers' Connectivity Needs
