Le Lézard
Classified in: Health
Subject: FDA

CSL Behring Delivers on its Continued Commitment to Alpha 1 Patients with FDA Approval of Convenient Single-Vial Dosing for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)]

KING OF PRUSSIA, Pa., April 25, 2019 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], its therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1).  This approval is significant for the Alpha 1 community as ZEMAIRA was previously available only in a 1-gram vial. The 4- and 5-gram packaging reduces the number of vials necessary for reconstitution, thereby adding convenience by saving patient's time and reducing waste.

FDA approves 4- and 5-gram vials of CSL Behring's ZEMAIRA(r).

ZEMAIRA dosing is weight-based, so a patient weighing 184 pounds currently requires five 1-gram vials.  With the larger vial sizes, a majority of patients will be able to streamline their preparation of ZEMAIRA to a single vial per dose, saving time and reducing waste by requiring them to reconstitute and pool fewer vials.  Room temperature storage coupled with the new larger vial sizes eases the burden of Alpha 1 therapy.

"Many Alpha 1 patients already experience the burden of weekly infusions," said Dr. Robert Sandhaus, MD, PhD, FCCP, Clinical Director, Alpha 1 Foundation and Medical Director, AlphaNet. "These larger vial sizes of ZEMAIRA are an improvement that could make it much easier for patients by simplifying the steps necessary for preparation of their therapy."

"We listened to our patients and are proud to address an unmet need for a new option that streamlines and expedites their current treatment regimen," adds Laurel Omert, MD, Medical Director, Specialty Products, North America, CSL Behring. "The addition of these larger vials to the ZEMAIRA family builds on our long history of innovation and commitment to the Alpha 1 community."

ZEMAIRA, a natural Alpha 1 protein derived from human plasma, has been proven to raise and maintain serum levels of alpha 1 antitrypsin protein (AAT) in patients. It has been available in the US market for over 15 years and is manufactured in Kankakee, Illinois.

About Alpha 1 Antitrypsin Deficiency
Alpha 1 Antitrypsin Deficiency is a hereditary condition that can severely affect a patient's lung function. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of AAT is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy.

ZEMAIRA is a highly-purified form of AAT (human) currently approved in the US, Canada, Brazil, and New Zealand, where it is indicated for chronic augmentation and maintenance therapy in adults with Alpha 1 Antitrypsin Deficiency and clinical evidence of emphysema.  CSL Behring markets ZEMAIRA as Respreeza® in Europe.

Important Safety Information
Alpha1-Proteinase Inhibitor (Human), ZEMAIRA is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.

ZEMAIRA may not be suitable for everyone; for example, people with known hypersensitivity to components used to make ZEMAIRA, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.

Early signs of hypersensitivity reactions to ZEMAIRA include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.

In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving ZEMAIRA: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.

Because ZEMAIRA is made from human blood, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Please see full prescribing information for ZEMAIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call1-800-FDA-1088.

About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 22,000 people, and delivers its life-saving therapies to people in more than 60 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.



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News published on 25 april 2019 at 08:37 and distributed by: