14:I[94367,["/_next/static/immutable/chunks/4370mg0uq-myq.js","/_next/static/immutable/chunks/0q7ni_ir0mogv.js","/_next/static/immutable/chunks/0q9_4lzwjwc3f.js","/_next/static/immutable/chunks/1p8rnjckwz-06.js","/_next/static/immutable/chunks/3zikwth1q5z_-.js","/_next/static/immutable/chunks/0eigul57_x91p.js","/_next/static/immutable/chunks/3r0kxtkfnobr8.js","/_next/static/immutable/chunks/260mvqou7a4l3.js","/_next/static/immutable/chunks/14bkwvgoktej3.js"],"NewsDetailPage"] 15:Tec5,

The FDA gave its approval to Zanvastro (zilganersen) for distribution to patients suffering from Alexander disease. This marks the first time in history that a drug for this rare and deadly disease has made it through FDA testing and approval. Unlike other medicines that help in alleviating symptoms, Zanvastro is an actual cure that fights against the disease on a cellular level.

Alexander disease is caused by mutations in the GFAP gene that affect glial fibrillary acidic protein production. If the GFAP protein becomes abnormal, it starts accumulating in cells and ruins the nervous systems of patients diagnosed with the disease. This disease occurs in one out of one million people and may cause seizures, developmental regression, difficulty walking, muscle weakness, and increased pressure inside the brain.

Zanvastro is classified as an antisense oligonucleotide, and its mechanism of action consists of blocking abnormal GFAP production before it becomes excessive. It is injected into the spinal cavity by a medical specialist once every three months.

The FDA reviewed data from an open-label sub-test study of four patients under two years old and a multicenter controlled clinical trial of 49 patients aged two and older. In children five years and older with established walking difficulties, Zanvastro appeared to provide enhanced walking speed by 61 weeks compared to the control group, while younger patients were assessed on a broader motor development scale. The FDA also considered pharmacokinetic modelling and available safety information when extending the indication to infants below two years, despite limited direct clinical data because of the rarity of the disease.

Reported common side effects include vomiting, back pain, cough, headache, and post-lumbar puncture syndrome. Aseptic meningitis has also been reported, requiring patients and caregivers to remain alert to symptoms that could indicate meningitis. This approval is important for India because it might sort out problems with diagnosis, doctors, genetic investigation, or access to necessary treatment concerning rare neurological disorders. Alexander disease is very rare, so many practitioners might see only a few cases in their lives.

Furthermore, the new treatment directed on the reduction of the abnormal production of GFAP highlights the relevance of genetic investigations in the treatment of rare diseases. For India, more opportunities for diagnosis, pediatric neurology, neurogenetics, and guidance will help to detect sick patients. Nevertheless, it is necessary to mention that FDA approval does not mean that the medicine will be available or it will be registered in India automatically.

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