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Ironwood/Allergan's Linzess sNDA Accepted for FDA Review
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Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and Allergan plc announced that their supplemental New Drug Application (sNDA) for the 72 mcg dose of Linzess for use in the treatment of adults with chronic idiopathic constipation (CIC) has been accepted for review by the FDA. The FDA is expected to respond early next year.
Approval of this dosage would provide patients with an additional treatment option. Currently, Linzess is approved by the FDA for the treatment of adults with CIC as a 145 mcg capsule to be taken once daily. Additionally, it is approved for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) as a 290 mcg capsule to be taken once daily.
According to information provided by the company in its press release, CIC is estimated to affect about 35 million adult Americans. According to a web-based survey commissioned by Ironwood and Allergan, it was found that only 12% of adult CIC sufferers are diagnosed medically. Moreover, very few prescription treatments are currently available for this condition.
During the first quarter, impressive growth was observed in LInzess, with U.S. net sales jumping 44% on a year-over-year basis and commercial margins expanding to 55%.
Ironwood has an agreement with AstraZeneca plc (AZN - Free Report) for the development and commercialization of Linzess in China, Hong Kong and Macau. Ironwood and AstraZeneca filed for marketing approval with the China Food and Drug Administration in Dec 2015, to market Linzess in China.
Ironwood is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Juniper Pharmaceuticals, Inc. , carrying a Zacks Rank #1 (Strong Buy).
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Ironwood/Allergan's Linzess sNDA Accepted for FDA Review
Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and Allergan plc announced that their supplemental New Drug Application (sNDA) for the 72 mcg dose of Linzess for use in the treatment of adults with chronic idiopathic constipation (CIC) has been accepted for review by the FDA. The FDA is expected to respond early next year.
Approval of this dosage would provide patients with an additional treatment option. Currently, Linzess is approved by the FDA for the treatment of adults with CIC as a 145 mcg capsule to be taken once daily. Additionally, it is approved for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) as a 290 mcg capsule to be taken once daily.
According to information provided by the company in its press release, CIC is estimated to affect about 35 million adult Americans. According to a web-based survey commissioned by Ironwood and Allergan, it was found that only 12% of adult CIC sufferers are diagnosed medically. Moreover, very few prescription treatments are currently available for this condition.
During the first quarter, impressive growth was observed in LInzess, with U.S. net sales jumping 44% on a year-over-year basis and commercial margins expanding to 55%.
Ironwood has an agreement with AstraZeneca plc (AZN - Free Report) for the development and commercialization of Linzess in China, Hong Kong and Macau. Ironwood and AstraZeneca filed for marketing approval with the China Food and Drug Administration in Dec 2015, to market Linzess in China.
Ironwood is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Juniper Pharmaceuticals, Inc. , carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>