One of AbbVie’s most highly anticipated pipeline candidates has reached the regulatory finish line. On Tuesday, the FDA approved Orilissa, a treatment for pain associated with endometriosis—and a potential blockbuster contributor to AbbVie's life after Humira biosimilars hit.
On Tuesday, the Illinois drugmaker, along with partner Neurocrine, said the FDA had approved the treatment for pain associated with endometriosis. It’s the first oral drug to win the agency’s favor for those patients in over a decade, and it's expected to roll out in early August bearing a price tag of $845 per month.
U.S. regulators green-lighted the product at two dosage strengths—150 mg for up to 24 months, and 200 mg for up to 6 months—and they didn't add black-box warnings or monitoring requirements for bone mineral density changes, Goldman Sachs analyst Jami Rubin wrote in a note to clients.
That's good news, she wrote. “We view the 24-month duration and clean safety labelling as a good outcome for the drug,” she wrote, noting that they should ease investor concerns about the drug’s safety. Those concerns ramped up after European regulators flagged liver injury reports among patients taking Allergan’s Esmya, a uterine fibroids drug seeking FDA approval. Orilissa could eventually compete against Allergan's therapy if it hits the U.S. market, and if Orilissa can win a second indication.
The way Rubin sees it, the new approval “should fully de-risk” Orilissa, including in the uterine fibroids space “to some extent.” Industry watchers expect a uterine fibroids OK by 2020.
In the meantime, though, the newcomer is “well positioned to hit management expectations of >$2bn by 2025,” Rubin wrote, adding that she and her colleagues model $65 million in sales for this year, with that sum swelling to $1 billion by 2020.
AbbVie has already begun priming the market for Orilissa’s arrival. In an attempt to raise awareness of the disorder—which affects an estimated one in 10 U.S. women of reproductive age—and shorten the timeline to diagnosis, the company has trotted out a doctor’s office TV ad and a campaign featuring Julianne Hough of “Dancing with the Stars.”
The news helped turn around AbbVie shares, which took a beating last week in part on a Citron Research tweet labeling the pharma giant “the next great drug short.”