Overview

On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.

On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.

Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.

Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys. Patients with Cushing's syndrome can have 'central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.

The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors. By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.

The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition. The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment. Corluxin was not compared with any other medicine.

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. The company had not yet responded to the last round of questions at the time of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”

The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product. The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.

On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.

In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.

The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.

Questions and answers on the withdrawal of the marketing authorisation application for Corluxin (mifepristone)

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Key facts

Name of medicine
Corluxin
Active substance
mifepristone
Therapeutic area (MeSH)
Cushing Syndrome
Anatomical therapeutic chemical (ATC) code
Not yet assigned
EMA product number
EMEA/H/C/002830

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation applicant
FGK Representative Service GmbH
Withdrawal of application
23/03/2015

All Documents

Withdrawal assessment report for Corluxin

Withdrawal letter: Corluxin

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