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Allergan's Belkyra Gets Swedish Approval for Double Chin
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Allergan plc announced that its prescription medicine, Belkyra (deoxycholic acid), has been granted marketing approval in Sweden for the treatment of moderate-to-severe fullness under the chin in adults, commonly referred to as double chin.
Belkyra was added to Allergan’s portfolio after the acquisition of Kythera Biopharmaceuticals in Oct 2015. In the U.S. and Canada, Belkyra is marketed under the trade name Kybella. It is also licensed in 10 other countries across the globe.
Belkyra was granted the Swedish Marketing Authorisation following an approval by the Swedish Medical Products Agency (MPA).
Belkyra is the first and only FDA-approved non-surgical injectable treatment for the reduction of moderate-to-severe submental fullness.
Note that Belkyra was evaluated in four phase III clinical studies involving more than 2,600 patients worldwide, two each in North America and Europe. Results from the studies demonstrated a high overall efficacy rate, as shown by a 1-grade improvement in fullness under the chin at 12 weeks after the last treatment. While European studies recorded a 63.8% improvement, North American trials witnessed a 78.5% improvement. Moreover, both the studies saw better improvement in the psychological impact caused by the fullness when treated with Belkyra compared to placebo.
According to data provided by the American Society for Dermatologic Surgery (ASDS), 67% of people with a double chin are bothered by the condition. Assuming further approvals in other European countries in the coming months, Allergan expects Belkyra to generate substantial revenues. Allergan’s prospects are quite impressive as well. The company has been actively pursuing acquisitions over the past few years and has been working on expanding its presence in the branded market. It is also working on expanding the labels of marketed products like Botox, Linzess and Restasis. It primarily focuses on core therapeutic areas like eye care, aesthetics, CNS, GI, anti-infectives, women's health and urology.
Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Exelixis, Inc. (EXEL - Free Report) and Amarin Corporation plc (AMRN - Free Report) . While BioMarin and Exelixis sport a Zacks Rank #1 (Strong Buy), Amarin carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates have narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 65.1% year to date.
BioMarin’s loss estimates have narrowed from 28 cents to 27 cents for 2016 and from $1.16 to $1.12 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 76 cents to 63 cents for 2016 and from 22 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.7% year to date.
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Allergan's Belkyra Gets Swedish Approval for Double Chin
Allergan plc announced that its prescription medicine, Belkyra (deoxycholic acid), has been granted marketing approval in Sweden for the treatment of moderate-to-severe fullness under the chin in adults, commonly referred to as double chin.
Belkyra was added to Allergan’s portfolio after the acquisition of Kythera Biopharmaceuticals in Oct 2015. In the U.S. and Canada, Belkyra is marketed under the trade name Kybella. It is also licensed in 10 other countries across the globe.
Belkyra was granted the Swedish Marketing Authorisation following an approval by the Swedish Medical Products Agency (MPA).
Belkyra is the first and only FDA-approved non-surgical injectable treatment for the reduction of moderate-to-severe submental fullness.
Note that Belkyra was evaluated in four phase III clinical studies involving more than 2,600 patients worldwide, two each in North America and Europe. Results from the studies demonstrated a high overall efficacy rate, as shown by a 1-grade improvement in fullness under the chin at 12 weeks after the last treatment. While European studies recorded a 63.8% improvement, North American trials witnessed a 78.5% improvement. Moreover, both the studies saw better improvement in the psychological impact caused by the fullness when treated with Belkyra compared to placebo.
According to data provided by the American Society for Dermatologic Surgery (ASDS), 67% of people with a double chin are bothered by the condition. Assuming further approvals in other European countries in the coming months, Allergan expects Belkyra to generate substantial revenues. Allergan’s prospects are quite impressive as well. The company has been actively pursuing acquisitions over the past few years and has been working on expanding its presence in the branded market. It is also working on expanding the labels of marketed products like Botox, Linzess and Restasis. It primarily focuses on core therapeutic areas like eye care, aesthetics, CNS, GI, anti-infectives, women's health and urology.
ALLERGAN PLC Price
ALLERGAN PLC Price | ALLERGAN PLC Quote
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Exelixis, Inc. (EXEL - Free Report) and Amarin Corporation plc (AMRN - Free Report) . While BioMarin and Exelixis sport a Zacks Rank #1 (Strong Buy), Amarin carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates have narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has soared 65.1% year to date.
BioMarin’s loss estimates have narrowed from 28 cents to 27 cents for 2016 and from $1.16 to $1.12 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 76 cents to 63 cents for 2016 and from 22 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.7% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>