- Fresh data suggest AbbVie could face competition from a much smaller biotech, Myovant Sciences, as both companies work to gain U.S. approval for their respective drugs as uterine fibroids treatments.
- Myovant said Tuesday its experimental therapy relugolix succeeded in a second Phase 3 uterine fibroids study, teeing up a New Drug Application submission by year's end to the Food and Drug Administration.
- AbbVie, meanwhile, plans to soon submit for an expanded label in uterine fibroids for Orilissa, a drug already approved for endometriosis, a company spokesperson confirmed to BioPharma Dive. Both drugs are GnRH receptor antagonists, a class of drugs which reduce production of a hormone that stimulates the growth of uterine fibroids.
Going up against a biotech major in AbbVie, Myovant's leaders will have their work cut out for them. Still, they believe Tuesday's study results will help their drug compete.
Myovant said 71% of patients treated with relugolix had significantly less menstrual bleeding, compared to 15% of the placebo group. The drug also showed significant improvements in anemia, bleeding and pain, among other areas.
"We feel very strongly that the clinical data we have in hand positions us extremely well to compete effectively in the marketplace," Myovant CEO Lynn Seely said in an interview with BioPharma Dive.
Myovant intends to submit its relugolix combination as a once-daily single tablet option, rather than as a regimen of pills. Separate clinical testing showed bioequivalence between the pill regimen and the single tablet, the biotech said Tuesday.
Dosing of Orilissa (elagolix) for uterine fibroids, by contrast, requires multiple pills. Both drugs are given in combination with a low dose of estradiol and a progestin. Myovant's CEO said the single dose will make it easier for women to take consistently.
Myovant is planning to field a commercial team between 150 and 200 people, focusing on the 36,000 gynecologists in the U.S. who account for the vast majority of prescriptions. This approach gives Myovant an avenue to reaching several million women, Seely said.
But battling commercially with AbbVie, if both drugs are approved, will be a tough test. Despite the Phase 3 successes, Myovant's stock has suffered, dropping by about 50% since the first late-stage results were released in May. Shares were down about 1% Tuesday morning.
Previously, Wall Street analysts had focused on the placebo-adjusted response rates for the two drugs, where relugolix lags Orilissa.
The new data does little to change that concern. Relugolix's placebo-corrected rates are 55% and 57% in its two late-stage studies, while AbbVie's drug notched higher rates of 60% and 66%.
Additionally, AbbVie's studies enrolled a higher percentage of African American women, who made up roughly two-thirds of the pharma's studies, while proportions in Myovant's were closer to 50%. Fibroids occur more often, appear to happen at younger ages and grow more quickly in African American women, according to the American College of Obstetricians and Gynecologists.
Myovant expects more data from use of its drug in other settings within the next few months. A Phase 3 study of relugolix in advanced prostate cancer is set to read out by year's end, and late-stage endometriosis studies will yield results in the first half of 2020.
Myovant in-licensed relugolix from Takeda in 2016 for territories outside of Japan and Asia.