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Allergan's Fibristal Approved in Canada for Label Expansion

AGN ANIK HSKA TEVA

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Allergan plc(AGN - Free Report) announced that it has received approval from Health Canada to expand the label of its drug Fibristal for the long term treatment of signs and symptoms of uterine fibroids.

Fibristal is already approved for the treatment of signs and symptoms of uterine fibroids. However, now the indication has broadened with the addition of long term safety and efficacy studies.

The treatment course is of three months.

Fibristal is a once-daily oral medication and according to the company’s press release it is the first and only non-surgical treatment specially indicated to treat the signs and symptoms of uterine fibroids.

Data from two long-term Phase III studies, PEARL III and PEARL IV  showed that Fibristal is able to control excessive uterine bleeding, lowers fibroid volume and reduces pain and symptoms associated with symptomatic uterine fibroids in the long term. Allergan claims that Fibristal, when taken in repeated courses, improves quality of life of patients and helps them to retain fertility. Moreover, the oral partial progesterone antagonist was well tolerated among most women as it doesn't induce menopause.

Around 70–80% Canadian women of reproductive age are said to suffer from uterine fibroids, which is the leading cause of hysterectomies in the country. The approval of Fibristal for long term intermittent use is going to help this patient group.

Allergan’s focus on growing its female health care product portfolio should bode well for long-term growth. The company is among the top 10 pharmaceutical companies globally, based on sales.

In order to focus on its branded segment, Allergan sold its generics business to Teva Pharmaceutical Industries Limited (TEVA - Free Report) .

Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Heska Corporation (HSKA - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . Heska sports a Zacks Rank #1 (Strong Buy) while Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.13 per share to $1.35 for 2016 and from $1.38 per share to $1.53 for 2017, over the last 60 days. The company posted positive surprises in each of the four trailing quarters, with an average beat of 301.64%.

Anika’s earnings estimates increased from $1.96 per share to $2.06 for 2016 and from $2.03 per share to $2.09 for 2017, over the last 60 days. The company posted positive surprises in each of the four trailing quarters, with an average beat of 33.14%.

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