Acromegaly and Huntington’s disease drugs win approval

Pfizer’s Somavert and Teva Handok’s Austedo approved as of Sept. 16

The South Korean health authority granted licenses for Pfizer Pharmaceutical Korea and Teva Handok, respectively.

 

Pfizer’s acromegaly treatment and Teva Handok’s Huntington’s disease treatment would be now accessible to the patients in need of treatment.

 

The Ministry of Food and Drug Safety (MFDS) granted approval on Somavert (pegvisomant) by Pfizer Pharmaceutical Korea and Austedo (deutetrabenazine) by Teva Handok as of Sept.

 

16.

 

Somavert injection is an incrementally modified drug with evidence submitted, whereas Austedo tablet is a novel drug.

 

Somavert is used to treat adults with acromegaly and intolerance or resistance in normalizing insulin-like growth factor 1 (IGF-1) with somatostatin analogues, and who respond inadequately to surgery or radiation.

 

Acromegaly is a hormonal disorder that enlarges hands, feet, forehead, and jaw as excessive level of growth hormone is excreted even after the growth plates have been closed.

 

About 60 out of one million people are diagnosed with the rare diseases, and usually the diagnosis is made from forties.

 

The main cause of the disorder is excess growth hormone produced by benign tumor in the pituitary gland.

 

However, relevant studies have not found the cause of the tumor, yet.

 

The recommended treatment is to remove the tumor in the pituitary gland with a surgery, but when the tumor is too big and cannot be removed completely, the patient has to receive radiation therapy and growth hormone-inhibiting medication simultaneously.

 

But many of the patients do not respond well to growth hormone-inhibiting drug, so the demand for more fundamental treatment is high.

 

The newly approved Somavert is a recombinant analogue of the human growth hormone, which blocks the growth hormone receptor and impedes signal transduction.

 

During a clinical trial conducted with 112 acromegaly patients, Somavert demonstrated statistically significant improvement in overall symptoms and relevant indicators than the placebo.

 

And approximately 93 percent of trial participants reached normalized IGH-1 level for 42.6 weeks.

 

Also approved on the same day, Austedo is a new drug used to treat symptoms of Huntington’s chorea, a kind of inherited diseases.

 

The Huntington’s disease is a rare progressive brain disorder caused by a mutated gene on chromosome 4.

 

According to Health Insurance Review and Assessment (HIRA), there were 286 patients with Huntington’s disease reported in South Korea as of 2018.

 

The most common symptom, also known as chorea, is abnormal motor behavior like sudden involuntary muscle spasms.

 

Approximately 90 percent of the patients with Huntington’s disease show the symptom.

 

Austedo conducted a clinical trial with 90 Huntington’s disease patients having chorea, but who can walk by themselves.

 

The trial compared the drug against placebo and confirmed the drug’s statistically significant effect with the evaluation indicator score.

 

The patient group taking Austedo reached 4.4 points, while the placebo group marked 1.9 points.