Shire just nabbed FDA panel backing for prucalopride, aiming to challenge Allergan and Synergy in the chronic constipation market—and to add blockbuster sales to a portfolio that’s at the heart of Takeda’s $62 billion buyout.
The vote couldn’t have come at a better time for the Japanese drugmaker, what with Takeda investors still balking at the deal. Adding a couple more boosts for Takeda’s quest, Japanese regulators approved the deal on Thursday, and a European gatekeeping committee backed approval for Shire’s Takhzyro (lanadelumab) to treat hereditary angioedema attacks.
The FDA advisory committee voted 10-0 in favor of prucalopride approval as Shire eased concerns about its potential to increase cardiovascular risks. CV worries have cropped up for other products in its class of 5-HT4 drugs, but Shire presented data that showed its drug doesn’t bear the same safety issues, the panel decided. Prucalopride works by amping up that serotonin receptor and stimulating muscular movement in the colon.
The FDA’s decision deadline for an approval is Dec. 21. The agency isn’t required to follow the advice of its expert panels but usually does. The drug is already approved in Europe under the brand name Resolor.
If prucalopride wins the FDA’s blessing, it’ll go up against Linzess, marketed by Allergan, and Trulance, the Synergy drug first approved in January 2017 and launched a few months later. Both drugs are cleared for chronic idiopathic constipation, prucalopride’s potential indication, and irritable bowel syndrome with constipation (IBS-C).
And both companies have been amping up their marketing. Linzess launched a direct-to-consumer ad campaign focusing on the many over-the-counter remedies that can fail patients with constipation—the very market that prucalopride will be targeting.
And in a quirky marketing move that’s attracted a lot of headlines, Synergy rolled out emojis, dubbed the Poop Troop, to encourage people to talk about their bowel movements.
Meanwhile, Synergy beefed up its sales force this year by bringing 200 reps in house full-time. That move came after Trulance’s new approval in IBS-C, but those sales folks are also touting the drug for its original use.
Shire hasn’t laid out its prucalopride marketing plans. But in touting its buyout of the U.K.-based drugmaker, Takeda has cited the drug as a solid sales prospect. The Japanese drugmaker is moving step by step toward closing that deal, now armed with approval in its home country. Opposition from some longtime shareholders, including family owners, isn’t expected to derail the acquisition.