Heron Therapeutic has finally won approval from the US Food and Drug Administration for its long-acting injection proposal to prevent nausea and vomiting caused by chemotherapy, Reuters reports.
The FDA nod is hard won, after being rejected twice previously, and marks the biotech company’s first regulatory approval. Soon after the announcement was made, Heron Therapeutic’s shares jumped by as much as 21% to $24 on Wednesday.
Nausea and vomiting are two of the most common side effects of chemotherapy treatments in cancer patients, occurring in up to 80% of them. These two combined are the primary reason for patients to stop treatment, says the National Institute of Health.
There are treatments to cure chemotherapy-induced nausea and vomiting (CINV), such as Eisai’s Aloxi injection. However, these are only effective for up to 48 hours.
Heron’s injection, Sustol, can prolong protection for as many as five days, according to the company.
In April, the FDA said it had found no deficiencies in Sustol’s applications, after having delayed its decision in January, then again in February.
Sustol was given approval in combination with other medications to prevent nausea and vomiting caused by certain forms of chemotherapy, but excluding platinum-based treatments, Heron reported.
The last bit is rather disappointing, as Sustol showed a strong response in patients undergoing this kind of chemotherapy. The exclusion lessens Sustol’s customer range by about 7%, Heron’s officials told Reuters.
Initial prices for the injection have not been disclosed, but Heron says it will use recently approved CINV treatments as a reference.
Sustol works by targeting the serotonin-3 (5-HT3) receptor, which contributes to nausea and vomiting. It is an injectable form of the generic granisetron.
The treatment will launch in the last quarter of this year. The company says it has a support plan ready, with co-pay assistance options to extend financing until practices are reimbursed, which would ideally repay patients if insurance claims are turned down.
Heron’s treatment is expected to generate some $306.3 million in sales by 2021, according to Thomson Reuters Cortellis.
