Corcept Therapeutics Announces Nine Poster Presentations on Mifepristone for the Treatment of Cushing’s Syndrome at the 97th Annual Endocrine Society Meeting – MarketWatch

ENDO_2015

 

Corcept Therapeutics Incorporated CORT,  a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders, today announced that a variety of posters about Korlym(R) (mifepristone) will be presented at the 97th annual Endocrine Society Meeting (ENDO 2015) being held at the San Diego Convention Center from March 5 – 7, 2015.

“We are pleased to see the breadth of new data being presented at ENDO 2015 about Korlym (mifepristone), which adds to the already substantial literature describing the use of mifepristone to treat Cushing’s Syndrome,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. “We are committed to bringing innovative therapies to patients in need, and we look forward to continuing our pivotal role in advancing the scientific understanding of Cushing’s syndrome and other rare and debilitating diseases.”

Multiple endocrinologists, researchers and centers of excellence are presenting a total of nine abstracts.

Read the entire article at Corcept Therapeutics Announces Nine Poster Presentations on Mifepristone for the Treatment of Cushing’s Syndrome at the 97th Annual Endocrine Society Meeting – MarketWatch.

EU Looks to Okay Ketoconazole for Use in Cushing’s Syndrome

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization for ketoconazole (Ketoconazole HRA; Laboratoire HRA Pharma) for the treatment of Cushing’s syndrome, a rare hormonal disorder sometimes called hypercortisolism.

Cushing’s syndrome is characterized by an excess of the hormone cortisol in the blood, which may be caused by a tumor. Treatment options currently available in the European Union include surgery to remove the tumor responsible for the high cortisol levels and radiotherapy, as well as several medicines that reduce the production of cortisol.

But pharmacological options remain very limited, and there is an unmet medical need for additional treatments, especially when surgery fails or for patients who cannot undergo surgery or take other medications. For this reason, the EMA’s CHMP evaluated the medicine under expedited review.

The opinion adopted by the CHMP at its September 2014 meeting is an intermediary step on Ketoconazole HRA’s path to patient access.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once a marketing authorization has been granted, decisions about price and reimbursement will then take place at the level of each member state considering the potential role/use of this medicine in the context of the national health system of that country.

The recommendation is that Ketoconazole HRA is to be prescribed only by physicians specialized in treating Cushing’s syndrome, as the dosing needs to be individualized for each patient.

This is because oral ketoconazole was previously suspended in the European Union for the indication it was first approved for, fungal infections, due to risk for liver injury. The US Food and Drug Administration (FDA) also decreed, at the same time, that doctors should no longer prescribe ketoconazole tablets as a first-line therapy for any fungal infection, for the same reason.

Information will be sent to healthcare professionals to allow them to advise patients and prescribe the medicine safely and effectively.

A Medicine Used Off-Label for More than 30 Years

Doctors have used ketoconazole to treat Cushing’s syndrome for more than 30 years, although it has never been authorized for this indication in the European Union. The drug is also frequently used off-label in the United States and elsewhere for this purpose.

The CHMP’s recommendation builds on information from published literature and documented off-label use in clinical practice.

At the time of the suspension of ketoconazole for fungal infections, healthcare professionals and patients were concerned that ketoconazole would no longer be available for patients with Cushing’s syndrome.

The CHMP therefore reviewed Ketoconazole HRA through accelerated assessment to facilitate patients’ access to a fully authorized medicine as soon as possible with evidence-based information for patients and doctors.

When assessing Ketoconazole HRA for the treatment of Cushing’s syndrome, the CHMP considered that “in this rare and potentially life-threatening condition, the medicine’s benefits are greater than its risks, which can be manageable in clinical practice by specific measures mitigating the risk of liver toxicity, including close monitoring of the patients’ liver function.”

In 2012, it was estimated that the disease affected approximately 46,000 people in the European Union. Cushing’s syndrome is a long-lasting condition that can be life-threatening because of its complications, including diabetes, high blood pressure, and depression.

From http://www.medscape.com/viewarticle/832399?src=rss

Skeletal Maturation in Children With Cushing’s Syndrome is Not Consistently Delayed

Skeletal maturation in children with cushing syndrome is not consistently delayed: The role of corticotropin, obesity, and steroid hormones, and the effect of surgical cure.

J Pediatr. 2014 Jan 9. pii: S0022-3476(13)01500-X. doi: 10.1016/j.jpeds.2013.11.065. [Epub ahead of print]

The Journal of Pediatrics, 01/22/2014 Clinical Article

Lodish MB, et al. – The aim of this study is to assess skeletal maturity by measuring bone age (BA) in children with Cushing syndrome (CS) before and 1–year after transsphenoidal surgery or adrenalectomy, and to correlate BA with hormone levels and other measurements. Contrary to common belief, endogenous CS in children appears to be associated with normal or even advanced skeletal maturation. When present, BA advancement in CS is related to obesity, insulin resistance, and elevated adrenal androgen levels and aromatization. This finding may have significant implications for treatment decisions and final height predictions in these children.

Methods

  • This case series conducted at the National Institutes of Health Clinical Center included 93 children with Cushing disease (CD) (43 females; mean age, 12.3 ± 2.9 years) and 31 children with adrenocorticotropic hormone–independent CS (AICS) (22 females, mean age 10.3 ± 4.5 years).
  • BA was obtained before surgery and at follow-up.
  • Outcome measures were comparison of BA in CD vs AICS and analysis of the effects of hypercortisolism, insulin excess, body mass index, and androgen excess on BA.

Results

  • Twenty-six of the 124 children (21.0%) had advanced BA, compared with the expected general population prevalence of 2.5% (P < .0001). Only 4 of 124 (3.2%) had delayed BA.
  • The majority of children (76%) had normal BA.
  • The average BA z-score was similar in the children with CD and those with AICS (0.6 ± 1.4 vs 0.5 ± 1.8; P = .8865).
  • Body mass index SDS and normalized values of dehydroepiandrosterone, dehydroepiandrosterone sulfate, androsteonedione, estradiol, and testosterone were all significantly higher in the children with advanced BA vs those with normal or delayed BA.
  • Fifty-nine children who remained in remission from CD had follow-up BA 1.2 ± 0.3 years after transsphenoidal surgery, demonstrating decreased BA z-score (1.0 ± 1.6 vs 0.3 ± 1.4; P < .0001).

From http://www.ncbi.nlm.nih.gov/pubmed/24412141

Cushing’s Awareness Patient Day

Saturday, February 1st, 2014

San Francisco, California

Hosted by Kate Tully, R.N. and Katherine Waidner, R.N.

Cushing’s Patient Advocates – Corcept Therapeutics

Agenda and details to follow

The day will focus on endogenous Cushing’s, a condition caused by high cortisol in your body.

The day will not cover exogenous Cushing’s caused by steroids taken for various health conditions including asthma, arthritis or lupus.

Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H2 2013

DUBLIN — Research and Markets  (http://www.researchandmarkets.com/research/h78zrm/pituitary_acth) has announced the addition of the “Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H2 2013” report to their offering.

‘Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H2 2013’ provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease), complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease).

Scope

– A snapshot of the global therapeutic scenario for Pituitary ACTH Hypersecretion (Cushing’s Disease).

– A review of the Pituitary ACTH Hypersecretion (Cushing’s Disease) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.

– Coverage of products based on various stages of development ranging from discovery till registration stages.

– A feature on pipeline projects on the basis of monotherapy and combined therapeutics.

– Coverage of the Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline on the basis of route of administration and molecule type.

– Key discontinued pipeline projects.

– Latest news and deals relating to the products.

Reasons to buy

– Identify and understand important and diverse types of therapeutics under development for Pituitary ACTH Hypersecretion (Cushing’s Disease).

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– Devise corrective measures for pipeline projects by understanding Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline depth and focus of Indication therapeutics.

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– Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.

Companies Mentioned

Isis Pharmaceuticals, Inc.

Ipsen S.A.

Novartis AG

Corcept Therapeutics Incorporated

HRA Pharma, SA

Cortendo Invest AB

Orphagen Pharmaceuticals, Inc.

For more information visit http://www.researchandmarkets.com/research/h78zrm/pituitary_acth

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