Aratana scores second FDA approval in two months for appetite drug for dogs

Aratana's Entyce
(Photo courtesy of Aratana)

Aratana Therapeutics ($PETX) has been promising investors three regulatory approvals this year, and now it’s two-thirds of the way toward reaching that goal. On May 17, the company announced that it had received FDA approval for Entyce (capromorelin), its appetite stimulator for dogs. The FDA nod comes two months after the agency approved Galliprant (grapiprant) to treat osteoarthritis pain in dogs.

But there’s one key difference between the two approvals: Aratana is taking on the full responsibility for commercializing Entyce, whereas it’s sharing the marketing burden for Galliprant with Eli Lilly’s ($LLY) Elanco. Aratana struck up a partnership with Elanco in late April. The two companies will co-promote the arthritis drug in the U.S., while Elanco will market it overseas.

In a conference call following Aratana’s earnings release on May 5, Aratana CEO Steven St. Peter said that he believes the company is well equipped to handle the Entyce rollout because it will be marketed initially to a small group of veterinary specialists. Galliprant, on the other hand, is entering a much more competitive market, with a half-dozen or so drugs being pitched to general practitioners.

Entyce is a flavored, liquid solution that mimics ghrelin, a naturally occurring hormone known to create the feeling of hunger. It was tested in dogs with a variety of conditions that impede appetite, including gastrointestinal and cardiovascular diseases, according to the product insert. More than 68% of dogs in the pivotal trial responded well to Entyce, versus 44% of dogs given a liquid that didn’t contain the drug.

"Nearly 10 million dogs are diagnosed with inappetence each year and we believe Entyce will fulfill a significant unmet need to stimulate appetite in dogs," said St. Peter in a press release announcing the approval.  

Next up for regulatory approval is Nocita (bupivacaine), a long-acting pain reliever for dogs that’s designed to be administered after surgery. In February, the company received the second of three required “section complete” letters from the FDA. If it receives the third this summer, as predicted, the company will be ready to launch the drug later this year, it has said.

Investors are applauding Aratana’s regulatory progress. Shares of the company rose 4% to $6.31 in morning trading the day after the latest approval, and they have more than doubled in price since mid-February.

- here’s the press release

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