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About Deflazacort (Calcort, Emflaza)
In February 2017, the U.S. Food and Drug Administration (FDA) approved Deflazacort (Calcort, Emflaza) tablets and oral suspension to treat patients age 2 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Deflazacort (Calcort, Emflaza) is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.

Both the American Academy of Neurology (AAN) and the Centers for Disease Control (CDC) guidelines recommend glucocorticoids as first-line therapy to improve muscle strength and function in patients with DMD, and are currently the only drugs that can definitely slow muscle decline in children with DMD. Help children extend the stage of walking on their own, and also reduce the risk of heart failure, lung function regression and scoliosis.
What is Duchenne Muscular Dystrophy (DMD)?
Duchenne Muscular Dystrophy (DMD) is a severe and life-threatening genetic paediatric disease. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. The first symptoms are usually seen between 3 and 5 years of age and worsen over time. The disease often occurs in people without a known family history of the condition and primarily affects boys, but in rare cases it can affect girls. DMD occurs in about one of every 3,500 male infants worldwide.

Patients affected by DMD have progressive loss of muscle function and weakness in their early childhood. This progressive muscle wasting typically leads to loss of ambulation around 10 years of age. It eventually spreads to the arms, neck and other areas. Cardiac dysfunction is present in most DMD patients and it is the primary cause of premature death.
DMD Clinical Treatment Methods
Deflazacort (Calcort, Emflaza)

Introduction of Drug Information

【Product Name】 Deflazacort
【General Name】 Emflaza
【Alias】 Calcort
【Manufacturer】 Sanofi-Aventis (Suisse) SA
【Specification】 Tablets: 6 mg
【Indications】 Deflazacort (Calcort, Emflaza) is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
【Dosage and Administration】 The recommended oral dosage of Deflazacort (Calcort, Emflaza) is approximately 0.9 mg/kg/day once daily.
Children under 2 years: Safety and efficacy have not been established.
【Mechanism of Action】 Deflazacort (Calcort, Emflaza) is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects.
【Precautions】 (1) Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, and hyperglycemia can occur; Monitor patients for these conditions with chronic use of Deflazacort.
(2) Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; Signs and symptoms of infection may be masked.
(3) Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels
(4) Gastrointestinal Perforation: Increased risk in patients with certain GI disorders; Signs and symptoms may be masked.
(5) Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
(6) Effects on Bones: Monitor for decreases in bone mineral density with chronic use of Deflazacort.
(7) Ophthalmic Effects: May include cataracts, infections, and glaucoma; Monitor intraocular pressure if Deflazacort is continued for more than 6 weeks
(8) Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting Deflazacort.
(9) Serious Skin Rashes: Discontinue at the first sign of rash, unless the rash is clearly not drug related.
Deflazacort (Calcort, Emflaza) Clinical Trials
Besides its many uses in the treatment of inflammations and autoimmune diseases2, the benefits of Deflazacort on DMD emerged from several studies. Corticosteroids are the standard therapy to delay DMD progression12 with some reports indicating less weight gain in patients using Deflazacort than those using other corticosteroids, like prednisolone.

In February 2017 Deflazacort received FDA approval for the treatment of DMD under the name Emflaza. This approval was based on a study of 196 boys, ranging from 5 to 15 years old. The study lasted 52 weeks and compared Deflazacort at two different dosages (0.9 or 1.2 mg/ kg/ day) with prednisone (another corticosteroid commonly used to treat DMD) and placebo.

After 12 weeks of treatment, both Deflazacort (at both dosages) and prednisone showed superior changes in average muscles strength scores: Deflazacort produced a score of 0.15 with the dosage of 0.9 mg/ kg/ d (95% CI 0.01, 0.28)16 and a score of 0.26 with the of dosage 1.2 mg/ kg/ d (95% CI 0.12, 0.40); prednisone produced a score of 0.27 (95% CI 0.13—0.41); placebo produced a score of -0.1 (95 % CI -0.23, 0.03).

Moreover, both medications were better than placebo on several timed motor function tests (i.e., time to stand from supine, time to climb four stairs and time to walk or run 30 feet). From week 12 to week 52 the group treated with Deflazacort with the dosage of 0.9 mg/ kg/ d showed better results in changes of average muscle strength score (0.17, 95% CI 0.03, 0.31) than the group treated with prednisone (-0.12, 95% CI -0.26, 0.03).

Conclusion: The muscle strength of the subjects who used Deflazacort was significantly improved compared with the placebo control group. Deflazacort was better tolerated, resulting in lower rates of weight gain and psychiatric adverse events.

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