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FDA approves drug to control life-threatening bleeding in patients with liver disease

A new five-day pill by Dova Pharmaceuticals won approval Monday. The pill is designed to temporarily build up platelet counts in patients with chronic liver disease so they can get a tooth pulled or a biopsy without risk of severe bleeding.
A new five-day pill by Dova Pharmaceuticals won approval Monday. The pill is designed to temporarily build up platelet counts in patients with chronic liver disease so they can get a tooth pulled or a biopsy without risk of severe bleeding. Dova Pharmaceuticals

Dova Pharmaceuticals received federal approval Monday for a first-of-its-kind drug to control life-threatening bleeding in people with chronic liver disease.

The Durham start-up plans to start selling the medication, named Doptelet, next month. The pill is designed for chronic liver patients who are planning a minor medical procedure that could cause severe bleeding, such as a tooth extraction, a biopsy or colonoscopy.

Dova said about 70,000 people with chronic liver disease have a low platelet count and can't form blood clots. They are at risk of uncontrolled bleeding and many require platelet transfusions on the day of a medical procedure, exposing them to the risk of infection and other complications.

The company estimates the potential value of the medication at $2.5 billion. A patient's cost for a five-day dose has not been announced, but Dova will offer introductory discounts and free samples.

Dova still needs to work out reimbursement deals with commercial insurers, but the all-in cost of a platelet transfusion, including side-effect management, is about $9,000, said Kevin Laliberte, Dova's senior vice-president of product development.

Like all drug developers, Dova also has to convince doctors — in this case, liver specialists — at more than 100 liver transplant centers to use the newly approved medication with their patients.

"One challenge of being the first medication approved is you have to try to alter what the doctor has been doing, usually with some success, for 3, 5 or more years," Laliberte said.

The U.S. Food & Drug Administration had put the medication, generically called avatrombapag, on priority review and approved it Monday. The drug stimulates platelet production and is the first such treatment approved for chronic liver disease patients awaiting medical procedures.

Shares fall

Dova was formed in 2016 and now has 120 employees, nearly half of whom work in Durham, the rest in sales around the country. Doptelet had been in development for about a decade under several pharmaceutical companies and was acquired in 2016 from Japanese drug maker Eisai by Charlottesville, Va.-based PBM Capital Group for an undisclosed price.

PBM then spun off Dova to develop the drug through commercialization, and Dova now owns the worldwide rights to Doptelet. The company issued publicly traded shares last June, raising about $75 million, and raised another $80 million from another public stock offering in February.

On Monday, trading in Dova stock was temporarily halted pending news of the FDA approval. Once trading resumed, shares jumped to $28.51, but ended the day at $24.16, down 13.20 percent.

Side effects

Doptelet is taken once a day for five days before a medical procedure, after which time the patient must wait five to eight days for the platelet count to increase. Taking Doptelet continuously would expose chronic liver disease patients to a risk of developing internal blood clots.

Doptelet has side effects on up to 10 percent of patients; the side effects include fever, abdominal pain, nausea headache and fatigue, according to the company.

Two other drug makers — GlaxoSmithKline and Amgen — make a medication for patients with low platelet counts, but those patients don't have chronic liver disease and take the medications for extended periods of time. Dova said it next plans to seek approval for Doptelet to be used for non-liver patients, like the GSK and Amgen medications.

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