We will answer your questions such as what is AGAMREE (Vamorolone), which is used in the treatment of Duchenne Muscular Dystrophy (DMD) and is approved by America, Europe, England and China, and what it is used for.
Vamorolone, also known as AGAMREE, is a novel medication candidate that binds to the same receptors as corticosteroids but alters the receptors’ downstream action. It is specifically a steroid-like drug that is being developed as an alternative to traditional corticosteroids, with the aim of offering similar therapeutic effects while causing fewer side effects.
Frequently Asked Questions About Agamree (vamorolone) Drug
What is Agamree (Vamorolone)?
Vamorolone is a synthetic, nonsteroidal glucocorticoid developed to act on the same receptors as corticosteroids, but with potentially reduced adverse effects. It works by modulating the glucocorticoid receptor in a way that can reduce inflammation, but with less impact on growth and bone health, which are common side effects of standard corticosteroid therapies.
Vamorolone is primarily being studied and used in the treatment of Duchenne muscular dystrophy (DMD), a rare, genetic disorder that causes progressive muscle weakness and degeneration.
What is Agamree (Vamorolone) Used For?
Agamree (vamorolone) has been specifically developed for use in Duchenne muscular dystrophy (DMD), a serious genetic disorder that primarily affects boys and leads to severe muscle weakness. In the clinical trials and research phase, vamorolone has been shown to:
- Improve muscle function and strength.
- Reduce inflammation and muscle damage, both of which are characteristic of DMD.
- Offers a treatment option that may avoid some of the severe side effects (such as growth inhibition, bone thinning, and other corticosteroid-related complications) that are commonly seen with traditional corticosteroid treatments like prednisone and deflazacort.
Vamorolone is considered a steroid alternative that could offer benefits similar to those of steroids but with a potentially improved side effect profile, especially in the long-term management of DMD.
Summary
- Agamree is the brand name for vamorolone.
- It is a glucocorticoid receptor modulator being researched and used primarily for Duchenne muscular dystrophy (DMD).
- It aims to reduce inflammation and muscle damage in DMD while offering a better side effect profile compared to traditional corticosteroids.
Where is AGAMREE (Vamorolone) Approved?
ReveraGen has granted Santhera an exclusive license to use vamorolone for all indications across the globe. The company has outlicensed the rights of vamorolone to Sperogenix Therapeutics for China and Catalyst Pharmaceuticals for North America.
The Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom and China’s NMPA have all authorized AGAMREE for the treatment of DMD. [Read More: Santhera Enters into Supply and Distribution Agreement for AGAMREE (Vamorolone) with Clinigen Group]
Who can use Agamree?
In October 2023, the U.S. Food and Drug Administration authorized Agamree for the treatment of DMD patients aged 2 and up. [Source: FDA]
Additionally, the treatment has been approved for DMD patients aged 4 and up in the U.K. and the European Union (as well as Iceland, Liechtenstein, and Norway). [Source: EMA]
Who should not use Agamree?
Those who have experienced adverse reactions to vamorolone, the active ingredient in Agamree, or any of its inactive constituents in the past should not use this medication. [Learn More: Agamree Label]
How does Agamree work?
Vamorolone, the main ingredient in Agamree, is a modified corticosteroid medication that lowers inflammation by preventing the synthesis of specific inflammatory chemicals known as cytokines. Its exact mechanism of action in Duchenne muscular dystrophy patients is unknown.
Agamree Price
Agamree (40 mg/mL) oral suspension costs approximately $10,013 for a 100 milliliter supply, depending on the drugstore you visit, according to information posted on Drugs.com.
Read More: Official Web Page of AGAMREE
