AMSTERDAM - The U.S. Food and Drug Administration (FDA) has approved argenx SE's VYVGART Hytrulo for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), marking the first approval of a neonatal Fc receptor (FcRn) blocker for this indication.
VYVGART Hytrulo, which is administered as a once-weekly subcutaneous injection, offers a new treatment mechanism for CIDP, a rare autoimmune disorder affecting the peripheral nervous system.
CIDP patients often suffer from mobility and sensory issues, with many requiring ongoing treatment and experiencing residual impairment. The FDA's decision is based on the results of the ADHERE Study, which showed that 69% of patients treated with VYVGART Hytrulo demonstrated clinical improvement. The study also met its primary endpoint, showing a 61% reduction in the risk of relapse versus placebo.
The introduction of VYVGART Hytrulo is expected to provide a significant advancement in the treatment of CIDP, which has seen limited innovation over the past three decades. Existing treatments primarily include corticosteroids and plasma-derived therapies, which can be burdensome for some patients.
argenx has announced that VYVGART Hytrulo will be available for patients in the U.S. immediately, with the typical patient's annual out-of-pocket cost expected to be comparable to current treatments for CIDP or generalized myasthenia gravis (gMG).
To support patient access, argenx has also established the My VYVGART Path program, offering resources such as disease and product education, access support, and financial assistance for eligible patients.
The safety profile of VYVGART Hytrulo was generally consistent with previous clinical studies and real-world use. The most common side effects reported include respiratory tract infection, headache, and urinary tract infection, along with injection site reactions.
This FDA approval further extends the therapeutic profile of the VYVGART franchise, which is also approved for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
argenx will hold a conference call today to discuss the approval. This article is based on a press release statement from argenx SE.
InvestingPro Insights
In the wake of the FDA's approval of argenx SE's VYVGART Hytrulo for CIDP, investors and stakeholders may be keen to understand the financial landscape of the company. With a market capitalization of $23.29 billion, argenx SE positions itself as a significant player in the biotech industry.
Despite not being profitable over the last twelve months, the company's revenue has seen an impressive growth of 126.96% during this period, underscoring the potential market demand for its innovative treatments.
The stock's performance has been noteworthy as well, with a strong return of 12.2% over the past month, highlighting investor confidence following recent developments. While argenx SE does not pay dividends, this growth-oriented strategy might appeal to investors looking for capital appreciation. It's also worth mentioning that the stock trades with low price volatility, which may provide some stability in a portfolio.
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