Grifols Announces Positive Results from Fanhdi Phase IV Study

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)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in PlantaDoce. A third-party contributor translated and adapted the articles from the originals. In case of discrepancy, the originals will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us