We would like to congratulate two of our client companies on achieving regulatory approval of their first products in Europe and USA.
On the 23rd February 2012, the European Commission granted PregLem Ltd, (now a division of Gedeon Richter) approval of Esmya™ (ulipristal acetate) for the pre-operative treatment of uterine fibroids.EMA approval of Esmya™.
Uterine fibroids are common benign tumours affecting between 20 and 25% of women of reproductive age. Approximately 300,000 surgical procedures are performed annually in the EU for uterine fibroids. The main symptoms are excessive uterine bleeding, anaemia, pain, frequent urination, and infertility. British Fibroid Trust. Until now, Gonadotrophin Releasing Hormone (GnRH) agonists were the only approved pre-operative treatment for uterine fibroids and their use has been relatively limited due to side effects resulting from the suppression of oestrogen to post-menopausal levels (hot flashes, depression, mood swings, loss of libido, vaginitis and loss of bone mineral density).
The approval of Esmya™ was based on the positive results from two double-blind trials (one versus placebo and one versus a GnRH agonist) that were published in NEJM earlier this year.Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids
It is a terrific achievment of PregLem to have acquired the rights to Esmya™ to have raised the necessary funds and to have completed a Phase III program and gain regulatory approval in less than 5 years from founding the company. A treatment course of Esmya™ is currently limited to 3 months in patients who are planning to have surgery. Longer term trials investigating the efficacy and safety of repeated intermittent courses of treatment are currently ongoing.Clinical Trials Registry
On July 26 2012, Amarin received FDA approval of Vascepa™ (formerly AMR101, a highly purified ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia.FDA approval of Vascepa™.
Severe hypertriglyceridemia refers to a condition in which patients have very high levels of triglycerides (greater than or equal to 500 mg/dL) in the bloodstream. Some familial disorders of triglyceride metabolism are associated with increased risk for pancreatitis; others are associated with increased atherosclerotic risk.
"FDA approval of Vascepa™ represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin's MARINE clinical trial, Vascepa™ demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as 'bad cholesterol,'"
Phase III clinical trial results of Vascepa™ were published last year.ANCHOR Study MARINE Study
The approval of Vascepa™ in July 2012 is a remarkable achievement for Amarin, as it is only approximately 5 years since the negative results of Phase III trials of AMR101 in patients with Huntington’s Disease. For the company to have sought funding and then successfully developed and gained approval of Vascepa™ for a completely different indication within 5 years is an amazing success.
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