Read about approvals and clinical trials
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.
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.
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
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.
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:
- 41.4% moderate to marked
- 73.4% slight to marked
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.
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.