BARCELONA, Spain - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a leading producer of plasma-derived medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded label for its 20% subcutaneous immunoglobulin (SCIg) product, XEMBIFY®, to include treatment-naïve patients with primary humoral immunodeficiencies (PI). This approval makes XEMBIFY the first 20% SCIg that can be administered to patients without prior intravenous therapy.
The FDA's decision is supported by phase 4 clinical trial data indicating that biweekly dosing of XEMBIFY is as effective as weekly dosing in maintaining appropriate total immunoglobulin (Ig) levels in patients. The trial, which included 27 subjects across 18 U.S. sites, showed no unique safety concerns and a consistent tolerability profile between the biweekly and weekly administration schedules.
This label expansion for XEMBIFY is set to offer greater flexibility and convenience to patients by eliminating the need for initial intravenous treatment and providing a biweekly dosing option. Joerg Schuettrumpf, Grifols' Chief Scientific Innovation Officer, highlighted the differentiation this brings to XEMBIFY compared to other SCIg therapies and the benefits of added convenience for patients.
The global market for Ig products is anticipated to see significant growth, particularly driven by the increase in primary and secondary immunodeficiencies, which together account for a substantial portion of the total Ig market. Grifols is positioning XEMBIFY as a key product within its broader business strategy focused on treating immunodeficiencies.
Plans for launching the new label in the U.S. are underway for the third quarter of 2024, with the biweekly dosing option already available in several European markets. Grifols is also working on introducing XEMBIFY in additional European countries. XEMBIFY is currently indicated for the treatment of PI in the U.S. and for both PI and select secondary immunodeficiencies in Europe, Canada, and Australia.
The information in this article is based on a press release statement from Grifols.
In other recent news, Grifols, a global frontrunner in plasma-derived medicines, announced that its subsidiary Biotest anticipates generating nearly $1 billion in revenue over the next seven years from its intravenous immunoglobulin (Ig) product, Yimmugo, in the United States.
This projection comes on the heels of the Food and Drug Administration's (FDA) recent approval of Yimmugo for the treatment of primary immunodeficiencies. The product is set to enter the U.S. market in the first quarter of 2025, as part of a seven-year agreement with Kedrion.
Yimmugo is the first product from Biotest's new FDA-certified production facility in Dreieich, Germany, to be commercialized in the U.S. The facility, dubbed Next Level, has already received the green light for production and marketing in Europe, where Yimmugo has been available since late 2022.
According to Roland Wandeler, President of Grifols Biopharma Business Unit, the company's distribution strategy is designed to maximize the availability of their top-tier Ig products across the U.S. Grifols is committed to expanding its portfolio of intravenous and subcutaneous Ig treatments within the U.S., with fibrinogen and trimodulin, currently in late-stage development, set to supplement Yimmugo.
InvestingPro Insights
As Grifols (MCE: GRF) gains momentum with the FDA's approval for an expanded label of XEMBIFY®, the company's financial health and shareholder value come into focus. With a consistent track record of maintaining dividend payments for an impressive 34 consecutive years, Grifols demonstrates a strong commitment to returning value to its investors. This dedication is further underscored by the company's profitability over the last twelve months.
In terms of financial performance, Grifols has experienced a revenue growth of 17.6% over the last twelve months as of Q4 2023, indicating a robust upward trajectory in its business operations.
Moreover, the company's gross profit margin stands at an exceptional 100%, reflecting the efficiency and effectiveness of its cost management strategies. Investors should also note the dividend yield of 3.72% as of November 2023, which is a testament to Grifols' ability to generate and distribute income to its shareholders.
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