Bimagrumab

Bimagrumab

Bimagrumab

Chemical compound

Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. It binds to and inhibits activin receptor type-2B.[1]

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Bimagrumab must be administered intravenously at a hospital or clinic. The medication has a long half life and is administered once a month.[2]

Development history

On August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US Food and Drug Administration.[3]

In 2014, Bimagrumab entered Phase II development, with some research indicating clinical effects.[4] Novartis planned to apply in 2016 for FDA approval to treat sIBM patients with bimagrumab.[5]

In April 2016, Novartis announced that bimagrumab had failed a Phase IIb/III study for sporadic inclusion body myositis.[6] In January 2021, a new study confirmed that treatment with Bimagrumab is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes.[7] In January 2023 the medication entered phase IIb trials for obesity.[2]

References

  1. [1]
    Garito T, Zakaria M, Papanicolaou DA, Li Y, Pinot P, Petricoul O, et al. (June 2018). "Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes". Clinical Endocrinology. 88 (6): 908–919. doi:10.1111/cen.13601. PMID 29566437. S2CID 5019650.
  2. [2]
    GlobalData Healthcare (2023-01-17). "Versanis' bimagrumab, first-in-class obesity therapy, enters Phase IIb of development". Pharmaceutical Technology. Retrieved 2023-05-27.
  3. [3]
    "Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Novartis AG. 23 August 2013. Archived from the original on 19 February 2014. Retrieved 20 August 2013.
  4. [4]
    Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, et al. (December 2014). "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83 (24): 2239–2246. doi:10.1212/WNL.0000000000001070. PMC 4277670. PMID 25381300.
  5. [5]
    "Novartis: Planned filings 2015 to >=2019" (PDF). Novartis Investor Presentation. 27 January 2015. Archived from the original (PDF) on 7 February 2015. Retrieved 27 May 2015.
  6. [6]
    Carroll J (21 April 2016). "Novartis' 'breakthrough' muscle drug bimagrumab flunks a late-stage trial". Fierce Biotech.
  7. [7]
    "Medication shows promise for weight loss in patients with obesity, diabetes". EurekAlert!. Retrieved 2021-01-20.
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