Pharmaceutical International News - April 2012
Signifor Drug Approval Marks Cushing’s Treatment First
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 27/04/2012 - 15:05:00
Drug regulators in the EU have approved the European launch of a new Cushing's disease treatment drug - Novartis' Signifor.
The move represents the first ever EU-based Cushing's disease drug approval and, according to Novartis, covers the treatment's supply to adult patients with this condition but only in instances when surgery's either not viable or already been performed, with unsatisfactory results.
Cushing's syndrome occurs as a result of high concentrations of the steroid hormone cortisol in the blood. One way this can happen is through the development of a specific type of brain tumour. This kick-starts a process that raises cortisol levels and this progression is unique to Cushing's disease.
Every 12 months, up to two million new Cushing's disease diagnoses are made and its symptoms include elevated blood pressure, selective obesity, fatigue and depression. In general, women are three times more susceptible than men and, in age terms, the condition most consistently develops in 20-to-50 year olds.
Cushing's Disease Treatment
Now, Novartis' Signifor has just emerged from a round of Cushing's disease treatment Phase III clinical trials. The results of these trials showed that cortisol levels dropped off in patients with Cushing's disease, provided with Signifor twice a day for six months, and it was on this basis that the drug was cleared for use by the European Commission.
‘The European Commission has approved Signifor (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed', Novartis explained in a company press release issued on 25 April 2012.
Signifor Drug Approval
"As the first therapeutic option to specifically target Cushing's disease, Signifor has the potential to redefine treatment of this debilitating disease", Novartis Oncology's President, Hervé Hoppenot, added in the same Signifor drug approval release.
"By focusing research efforts on our understanding of this rare disease where there is significant unmet need, we have been able to successfully bring a novel treatment option to patients in the European Union."
Image copyright Novartis AG
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