The China Center for Drug Evaluation (CDE) has recently granted Harbour BioMed the Breakthrough Therapy designation for batoclimab, a treatment for adults with myasthenia gravis (MG). This designation was created for drugs that treat severe or life-threatening conditions that also demonstrate an improvement over existing therapies.
About Myasthenia Gravis
Myasthenia gravis is an autoimmune, neuromuscular disorder that is characterized by weakness and fatigue in the voluntary muscles that worsens with physical activity. In affected individuals, the body mistakenly attacks itself, specifically the proteins that are needed for communication between the nerves and muscle cells. Although there is no cure, doctors can treat MG with steroids, surgery to remove the thymus gland, and plasmapheresis. Other therapies may be necessary to manage symptoms as well.
Common symptoms of MG include:
- Drooping eyelids
- Issues with chewing and swallowing
- A change in gait
- Weakness and fatigue in the neck and limbs
- Double vision
- Slurred speech
About Batoclimab
Batoclimab is a fully human anti-FcRn mAb that was designed to block FcRn-IgG interactions. This allows for autoantibodies to degrade at a faster pace, therefore treating a number of autoimmune diseases. It is administered via subcutaneous injection.
Because batoclimab received the Breakthrough Therapy designation, it will be able to go through development and review at a faster pace. Harbour hopes that it will be able to reach patients soon.
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