Ironwood (IRWD), AbbVie Get FDA Nod for Linzess Label Expansion
Ironwood IRWD announced that the FDA has approved Linzess (linaclotide) as a once-daily treatment for functional constipation in pediatric patients aged 6-17 years. This approval for the new indication marks a milestone for IRWD as Linzess becomes the first and only FDA-approved prescription therapy for functional constipation in pediatric patients.
The drug was launched in 2012 for patients suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). With a strong market demand, Linzess is a leading brand in treating gastrointestinal diseases in the United States. More than 4.5 million adult patients with IBS-C and CIC have been treated with the drug since its launch.
In December 2022, partner AbbVie ABBV filed a regulatory application with the FDA, seeking expanded use of Linzess to treat functional constipation in pediatric patients.
Shares of Ironwood nosedived 7.8% year to date compared with the industry’s 2.5% decline.
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Functional constipation in children is a chronic condition, characterized by infrequent and hard bowel movements that are often painful. It is estimated that approximately 6 million children, aged 6-17 years, in the United States are affected by this health condition.
The FDA approval for the use of Linzess in pediatric population was based on data from a large double-blind phase III study that evaluated the drug’s effectiveness in patients with functional constipation. The study involved 328 patients who were randomized to receive either Linzess 72 mcg or a placebo.
The results showed that linaclotide demonstrated a statistically significant and clinically meaningful improvement compared to placebo. The linaclotide-treated patients experienced more than a two-fold increase in spontaneous bowel movements per week compared to the other group.
Ironwood co-develops and co-commercializes Linzess with partner AbbVie. Linzess is marketed by AbbVie in Europe and Canada under the brand name, Constella. Ironwood receives royalties on sales of Constella in these two regions.
Ironwood has partnered with AstraZeneca for the development and commercialization of Linzess in China. It has also joined forces with AbbVie for the global development and commercialization of linaclotide.
In the first quarter of 2023, Ironwood’s share of net profits from the sales of Linzess in the United States was $101.6 million, up 8% year over year. This can be attributed to an acceleration in new prescription volume. The new prescription demand increased 10% from that recorded in the year-ago period.
Ironwood Pharmaceuticals, Inc. Price and Consensus
Ironwood Pharmaceuticals, Inc. price-consensus-chart | Ironwood Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Ironwood currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimate for Akero Therapeutics has narrowed from $3.46 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have risen 1% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have nosedived 1.5% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
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