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Grifols Announces Positive Results from Fanhdi Phase IV Study

Grifols reports positive results from its Phase IV study of Fanhdi for von Willebrand disease (VWD) treatment, showing safety and efficacy. Presented at the 2024 World Congress of the World Federation of Hemophilia, the study achieved 100% efficacy.D ouble-inactivated human anti-hemophilic factor, Fanhdi, is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A.




Good news for Grifols. The Catalan multinational blood products company announced today that its recently completed Phase IV observational study of Fanhdi has shown positive results in terms of the safety and efficacy of the product for the prophylaxis and treatment of patients with von Willebrand disease (VWD). Grifols will present the data today at the 2024 World Congress of the World Federation of Hemophilia, in Madrid.

von Willebrand disease is an incurable bleeding disorder that affects the blood’s ability to clot properly. It is the most common hereditary blood clotting disorder and, in Spain alone, it is estimated that this rare disease affects 122 patients per million.

The company conducted this phase IV prospective, observational, multicenter cohort study to evaluate the safety and clinical efficacy of long-term Fanhdi use in patients with VWD (von Willebrand disease). The overall clinical efficacy of treatment with Fanhdi (including on-demand treatment and prophylaxis) achieved an excellent or good rating of 100%, as assessed by the investigator, with no relevant safety concerns reported during the study.

Grifols has achieved this milestone after testing its solution on 17 participants

“This observational study further reinforces the potential long-term effectiveness of Fanhdi for the treatment of bleeding episodes and as prophylaxis before surgical procedures,” said Jörg Schüttrumpf, director of scientific innovation at Grifols.

A total of 17 participants were included in the study, which lasted twelve months, and fifteen of them received at least one dose of Fanhdi. Efficacy was evaluated during 46 bleeding episodes reported by nine patients (60% of the total) and during six surgical or invasive procedures reported by six (33.3%) patients.

Double-inactivated human anti-hemophilic factor, Fanhdi, is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A. It may be useful in the management of acquired FVIII deficiency. Fanhdi is also indicated for the treatment of bleeding and treatment and prophylaxis of surgical bleeding in patients with von Willebrand disease (VWD) when treatment with desmopressin (Ddavp) alone is ineffective or contraindicated.

Grifols past problems

New episode in the Grifols case. The Millenium International Management fund has decided to reopen a short position on the Catalan pharmaceutical company equivalent to 0.53% of its capital, after several days in which the value has been affected by the volatility caused by the report from the also bearish Gotham CityResearch.

Specifically, according to the records of the National Securities Market Commission (CNMV), Millenium opened its position on Grifols yesterday. At the closing price, yesterday Tuesday, the 2.26 million shares that confirm the short position would be valued at 20.3 million euros, according to the theoretical calculation carried out by Europa Press.


(Featured image by Julia Koblitz via Unsplash)

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Eva Wesley is an experienced journalist, market trader, and financial executive. Driven by excellence and a passion to connect with people, she takes pride in writing think pieces that help people decide what to do with their investments. A blockchain enthusiast, she also engages in cryptocurrency trading. Her latest travels have also opened her eyes to other exciting markets, such as aerospace, cannabis, healthcare, and telcos.