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
- The Food and Drug Administration (FDA) is a significant entity in the health-and-wellness industry, making decisions on various drugs for numerous diseases.
- These decisions can have a profound impact on the lives of those suffering from medical-conditions, such as chronic-diseases or respiratory-conditions.
- One such medical-condition is bronchiectasis, for which Brinsupri, a dipeptidyl peptidase 1 inhibitor, has already been approved.
- Fibromyalgia, another medical-condition, may soon have a new treatment option in the form of Tonmya, a sublingual formulation of cyclobenzaprine hydrochloride.
- Recurrent Respiratory Papillomatosis, a rare and lifelong neoplastic lung disease, could see a new treatment with Papzimeos, an adenoviral vector-based immunotherapy.
- Wet Age-Related Macular Degeneration, a vision-threatening eye-health issue, might find relief with Outlook Therapeutics' ONS-5010.
- Unfortunately, there have been no recent FDA approvals for drugs targeting Alzheimer's Disease, Friedrich's Ataxia, Hereditary Angioedema, or Immune Thrombocytopenia.
- However, Ionis Pharmaceuticals' donidalorsen for Hereditary Angioedema and Sanofi's rilzabrutinib for Immune Thrombocytopenia are currently under review by the FDA.
- The FDA is also considering Tonix Pharmaceuticals' TNX-102 SL for fibromyalgia and Outlook Therapeutics' ONS-5010 for Wet Age-Related Macular Degeneration.
- For bronchiectasis, the FDA is reviewing Insmed's brensocatib, an oral DPP1 blocker.
- Precigen is pushing forward with PRGN-2012 for Recurrent Respiratory Papillomatosis.
- In the realm of Alzheimer's Disease, Biogen and Eisai have submitted a subcutaneous maintenance formulation of their anti-amyloid therapy Leqembi for FDA approval.
- These proposed drugs and therapies fall under various industries, including the pharmaceutical, medical-research, and healthcare industries.
- Some of these treatments also intersect with futuristic fields like artificial-intelligence and genetic-engineering.
- The FDA's decision on these drugs can have a significant impact on the investing, wealth-management, and financial sectors, as well as on personal-finance and banking-and-insurance.
- The medical-tourism, home-and-garden, and lifestyle industries could also be affected, as people may travel for these treatments.
- Additionally, the approval of these drugs could spark discussions in politics, general-news, and pop-culture.
- If approved, many of these drugs and therapies could revolutionize the current landscape of respiratory-health, eye-health, and skin-health.
- They might also contribute significantly to the treatment of neurological-disorders, digestive-health, cardiovascular-health, and mental-health.
- Autoimmune-disorders, skin-conditions, and chronic-pains like fibromyalgia could find potential relief.
- Furthermore, these treatments could potentially improve environmental-science by reducing the environmental impact of certain diseases or disorders.
- Climate-change might also play a role in disease prevalence and treatment, making it crucial for these decisions to take that into account.
- The FDA's decisions could also have implications for the therapy-and-treatment, nutrition, and fitness-and-exercise sectors, as well as for the health-and-wellness and fashion-and-beauty industries.
- The treatment of hereditary-disorders could also see a significant advancement, thanks to the potential approval of donidalorsen and the subcutaneous formulation of Leqembi.
- The approval of these treatments could also spur the development of new therapies and treatments for several diseases and conditions.
- The fate of these treatments will be decided by the FDA, which is expected to release its decisions in the coming weeks.
- Whether these treatments will be approved or rejected, the FDA's decisions will undoubtedly influence the future of healthcare, science, and the overall well-being of millions worldwide.
