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Where has Ketas (ibudilast) been approved?

Ketas (ibudilast) was approved for the treatment of patients with bronchial asthma and cerebrovascular disorders by: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, May 1989.

Ibudilast was granted orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS) by the European Medical Agency (EMA), European Union, on December 12, 2016 and by the Food and Drug Administration (FDA), USA, on June 10, 2016. Note: This means the medicine has not been approved by the EMA or the FDA but due to the seriousness of the condition, the lack of alternatives for diagnosis, prevention or treatment or the rarity of the condition, the medicine is treated with special care by the regulatory agencies.

Clinical trials

Cerebrovascular disorders

The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, approvals of Ketas (ibudilast) for cerebrovascular disorders, in particular improvement of dizziness for patients with sequelae of cerebral infarction, was based on a double-blind clinical study

In this study, this product or a placebo was given to patients for 8 weeks after an initial observation period of 4 weeks. During the observation period, placebo was given and patients with poor compliance or who didn’t have any symptoms were removed from the study.

Results

The main outcome measured was improvement of dizziness. Ketas (ibudilast) saw better results than placebo within the measured outcome. The improvement rate of dizziness was:

- 50.0% (47/94) for Ibudilast

- 18.7% (20/107) for placebo

Bronchial asthma

The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, approvals of Ketas (ibudilast) for bronchial asthma was based on clinical studies including a double-blind study.

Results

The efficacy outcome measured was improvement rate: from moderate to marked, and slight to marked. The double-blind clinical study demonstrated that Ketas (ibudilast) is effective to treat bronchial asthma. The improvement rate (%) was:

Total

- 41.4% moderate to marked

- 73.4% slight to marked

ALS

The effects of ibudilast on ALS patients have been evaluated in experimental models. Clinical trials were ongoing at the time the orphan designation was granted.

References:

Summary of Product Characteristics [PMDA]: Ketas (ibudilast) [PDF], Kyorin Pharmaceutical Co, Ltd, May 2013.

EMA Orphan Designation: ibudilast. www.EMA.europa.eu, 12/12/2016.

Orphan Designation: ibudilast. www.accessdata.fda.gov, 10/06/2016.

Orphan Designation, www.ema.europa.eu, cited on 15/06/2018.

Designating an Orphan Drug, www.fda.gov, cited on 15/06/2018.

What is Tudcabil (tauroursodeoxycholic acid)?

Tudcabil (tauroursodeoxycholic acid) is a compound originally approved to treat liver diseases, although research suggests it may have a broader application which includes the treatment of amyotrophic lateral sclerosis (ALS). Tauroursodeoxycholic acid is a bile acid taurine conjugate derived from ursodeoxycholic acid. Bile acid is made by the liver and stored in the gallbladder and helps with digestion. It has a role as a human metabolite, an anti-inflammatory agent, a neuroprotective agent, an apoptosis inhibitor, a cardioprotective agent and a bone density conservation agent.

Where has Tudcabil (tauroursodeoxycholic acid) been approved?

Tudcabil (tauroursodeoxycholic acid) is approved in Italy for the treatment of liver diseases. Tudcabil (tauroursodeoxycholic acid) is not approved for amyotrophic lateral sclerosis (ALS), but was granted orphan designation for ALS by the European Medicines Agency (EMA) (EU, February 2017).

References:

Public summary of opinion on orphan designation [EMA]: Tudcabil (tauroursodeoxycholic acid) [PDF], Bruschettini s.r.l., cited on March 2017.

Atto Completo [Italy Ministry of Health]: Tudcabil (tauroursodeoxycholic acid), cited on November 2003.