Dive Brief:
- Argenx on Thursday gave investors two pieces of positive news about its first marketed drug, Vyvgart, reporting sales that beat analyst expectations and successful study results that could help expand use of the medicine. Shares of the company rose 10% in early trading.
- The Dutch drugmaker won approval for Vyvgart in December to treat generalized myasthenia gravis, an autoimmune disease that causes weakness in muscles needed for everything from walking to breathing. Patients receiving the therapy get a one-hour infusion each week for four weeks and repeat the cycle if needed after a break.
- Researchers are studying a longer course of treatment in patients who suffer from another autoimmune disorder, primary immune thrombocytopenia, which lowers platelets in the body and can cause excessive bleeding, bruising or even brain hemorrhages. The new Phase 3 trial found Vyvgart helped patients achieve and maintain higher platelet counts than did a placebo.
Dive Insight:
Argenx is well-positioned for growth with the new trial data and a “big revenue beat” for Vyvgart in the first quarter, Piper Sandler analyst Allison Bratzel wrote in a note to investors. The drug pulled in net sales of $21.2 million in the period, surpassing the consensus Wall Street estimate of $7 million and Piper Sandler’s expectation of $5.1 million, Bratzel wrote.
The Phase 3 ADVANCE trial in primary immune thrombocytopenia found that 22% of patients receiving Vyvgart had a sustained platelet response, compared with 5% of patients on placebo, a statistically significant difference. Importantly, the safety profile of the drug was consistent with previous studies, even though patients in the new trial were treated for 24 weeks, Argenx said.
ADVANCE included 131 adults with primary immune thrombocytopenia who had already received an array of other treatments. About two-thirds of the participants had received three or more therapies for their condition before enrolling in the new trial.
The study is the first of two pivotal trials the company is conducting for the potential new indication. The second, ADVANCE-SC, will likely have top-line data in the first quarter of 2023, Argenx said.