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Antihemophilic Factor News

FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A

Posted 8 Jun 2016 by Drugs.com

KING OF PRUSSIA, Pa. — 26 May 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved Afstyla [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. Afstyla is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualized spontaneous bleeding rate (AsBR) of 0.00. Once activated, Afstyla is identical to natural factor VIII. Clinical trials of Afstyla demonstrated a strong safety profile with no inhibitors observed. Afstyla is indicated in adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding e ... Read more

Related support groups: Hemophilia A, Antihemophilic Factor, Afstyla

FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A

Posted 18 Mar 2016 by Drugs.com

WHIPPANY, N.J., March 17, 2016 /PRNewswire/ – The U.S. Food and Drug Administration has approved Bayer's Kovaltry Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which supported the approval of Kovaltry for routine prophylaxis to reduce the frequency of bleeding episodes. Kovaltry can be used two or three times per week in adolescents and adults, and two or three times per week or every other day in children. "In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis," said Sanjay P. Ahuja, MD, LEOPOLD investigator and Director, Hemostasis & Thrombosis Center ... Read more

Related support groups: Hemophilia A, Antihemophilic Factor, Kovaltry

FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A

Posted 16 Nov 2015 by Drugs.com

November 13, 2015 – The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. Adynovate is approved for on-demand (as needed) treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes (prophylaxis) in patients with Hemophilia A. Adynovate consists of the full-length Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood. “The approval of Adynovate provides an important therapeutic opt ... Read more

Related support groups: Hemophilia A, Antihemophilic Factor, Adynovate

FDA Approves Nuwiq (Antihemophilic Factor [Recombinant]) for Hemophilia A

Posted 17 Sep 2015 by Drugs.com

HOBOKEN, N.J. September 15th, 2015: Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The Nuwiq approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding. Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with Hemophilia A, congenital FVIII deficiency. Hemophilia A impacts the lives of up to 16,000 individuals in the U.S. and their caregivers. Although present therapies for Hemophilia A treatment exist in the U.S., significant challenges still remain, including development ... Read more

Related support groups: Hemophilia A, Hemophilia, Antihemophilic Factor, Nuwiq

Kids' Hemophilia Drugs a Big Part of State Medicaid Spending

Posted 31 Jul 2015 by Drugs.com

FRIDAY, July 31, 2015 – Treatment costs for one childhood illness, hemophilia, may use up a big chunk of a state's Medicaid budget, a new study out of California shows. The researchers found that treatments for hemophilia – a rare, inherited disorder in which blood does not clot normally – accounted for the largest share of spending on outpatient drugs among publicly insured children in California with serious chronic illnesses. The study "underscores the potential effect of new, expensive but [effective] pharmaceuticals on public insurance programs for children with chronic illness," wrote a group led by Sonja Swenson of Stanford University. Her team published the findings July 28 in the Journal of the American Medical Association. The researchers tracked 2010-2012 data from more than 34,300 publicly insured children and young adults under the age of 21 in California with serious ... Read more

Related support groups: Hemophilia A, Hemophilia B, Hemophilia, Antihemophilic Factor, Advate, ReFacto, Koate-DVI, Haemate P, Monoclate-P, Obizur, Alphanate, Kogenate, Helixate FS, Recombinate, Bioclate, Kogenate FS, Antihemophilic Factor/Von Willebrand Factor, Hemofil-M, Replenate, Factane

FDA Approves Obizur [Antihemophilic Factor (Recombinant)] for Acquired Hemophilia A

Posted 27 Oct 2014 by Drugs.com

DEERFIELD, Ill., October 24, 2014 - Baxter International Inc. today announced that the United States Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder. Obizur was granted orphan-drug status by the FDA and its review was prioritized based on AHA's classification as a rare disease and the potential for the treatment to address an important unmet medical need. Obizur is the first recombinant porcine FVIII treatment approved for AHA that allows physicians to manage the treatment's efficacy and safety by measuring factor VIII activity levels in addition to clinical assessments. Obizur replaces the inhibited human factor VIII with a recombinant porcine sequence factor VIII based on ... Read more

Related support groups: Hemophilia A, Hemophilia, Antihemophilic Factor

FDA Approves Eloctate - first Antihemophilic Factor, Fc Fusion Protein for Patients with Hemophilia A

Posted 9 Jun 2014 by Drugs.com

June 6, 2014 – The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Eloctate is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Eloctate consists of the Coagulation Factor VIII molecule (historically known as Antihemophilic Factor) linked to a protein fragment, Fc, which is found in antibodies. This makes the product last longer in the patient’s blood. “The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A,” said Karen Midthun, M.D., ... Read more

Related support groups: Hemophilia A, Antihemophilic Factor

New Hemophilia Remedy Eloctate Offers Potential for Fewer Injections

Posted 9 Jun 2014 by Drugs.com

MONDAY, June 9, 2014 – Eloctate, Antihemophilic Factor Fc Fusion has been approved by the U.S. Food and Drug Administration for people with Hemophilia A. It's designed to require less frequent injections than standard therapies used to reduce the frequency of bleeding episodes in people with the disorder, the FDA said in a news release. Hemophilia A is an inherited bleeding disorder that affects mostly males. Caused by a defective Factor VIII gene, it affects about 1 in 5,000 males in the United States. People with the disorder are prone to serious bleeding episodes, primarily affecting the joints. Eloctate's safety and effectiveness were evaluated in a clinical study of 164 people. No safety concerns were identified in the trial, the FDA said. The product is produced by Biogen Idec, based in Cambridge, Mass. More information The FDA has more about this approval. Read more

Related support groups: Hemophilia A, Antihemophilic Factor

NovoEight (turoctocog alfa) Receives Approval from the FDA

Posted 21 Oct 2013 by Drugs.com

Bagsværd, Denmark, 16 October 2013 – Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight. The FDA approved Novoeight for use in adults and children with hemophilia A for: Control and prevention of bleeding Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Novoeight has been studied in the guardian™ clinical programme; one of the largest and most comprehensive pre-registration clinical trial programmes in the field of hemophilia therapy with more than 210 severe hemophilia A patients. In the completed trials Novoeight® demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, and all patients in the surgery trial were treated effectively. Novoeight® will be lau ... Read more

Related support groups: Hemophilia A, Antihemophilic Factor

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Hemophilia A

Related Drug Support Groups

ReFacto, Advate, Adynovate, Recombinate, Bioclate, Biostate, Afstyla, Monarc-M, Liberate, view more... Monoclate, Monoclate-P, Hyate:C, Replenate, Genarc, Advate rAHF-PFM, Kovaltry, Nuwiq, Koate-DVI, Koate-HP, Kogenate, Kogenate Bayer, NovoEight, Kogenate FS, Kogenate FS with Bioset, Beriate P, Helixate, Helixate FS, Helixate NexGen, Factane, Fanhdi, Eloctate, Hemofil-M, Obizur, Xyntha

Antihemophilic Factor Patient Information at Drugs.com