07/27/2021 | Press release | Distributed by Public on 07/27/2021 00:23
July 27, 2021
Barcelona, Spain, and Tokyo, July 27, 2021 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), one of the world's leading producers of plasma-derived medicines with a more than 100-year track record of contributing to the health and well-being of people around the world, and OrphanPacific, Inc., which provides drugs for rare diseases and disorders in Japan, today announced the beginning of the commercialization of Lynspad™ (intravenous infusion 1000mg), an alpha-1 proteinase inhibitor to treat severe alpha-1 antitrypsin deficiency (AATD) in the country.
Japan's Ministry of Health, Labour and Welfare (MHLW) granted manufacturing and marketing approval on January 22, 2021.
Grifols developed Lynspad™ (sold as Prolastin-C® in other markets) and designated OrphanPacific as the Appointed Marketing Authorization Holder (AMAH) to obtain manufacturing and marketing approval for the AATD treatment in Japan under the Foreign Exceptional Approval System, an approach for a company intending to commercialize an overseas-manufactured product in Japan without a license to manufacture and distribute pharmaceutical products in the country.
Lynspad™ is used to treat patients diagnosed with severe AATD [serum alpha-1 antitrypsin level < 50 mg/dL (measured by nephelometry)] and presenting with pulmonary disease such as chronic obstructive pulmonary disease (COPD) and emphysema accompanied by airflow obstruction.
In patients with AATD, serum and tissue levels of alpha-1 proteinase inhibitor are reduced, resulting in an imbalance between neutrophil elastase and its inhibitor, alpha-1 proteinase inhibitor. The imbalance causes inappropriate proteolysis in lung tissue, but Lynspad™ augmentation therapy enhances protection against proteinases by increasing and maintaining the level of alpha-1 proteinase inhibitor in serum and pulmonary airway epithelial lining fluid, and corrects proteinase vs. inhibitor imbalance. It is believed that correction of this imbalance suppresses the onset and progression of emphysema and delays the progression of pathological condition of COPD.
|Product Name||Lynspad™ for Intravenous Infusion 1000mg|
|Common Name||Alpha-1 Proteinase Inhibitor (Human)|
|Indication||Severe alpha-1 antitrypsin deficiency|
|Dosage and Administration||For adults, 60 mg/kg is normally intravenously infused once a week as Alpha1-Proteinase Inhibitor (Human).|
Lynspad™ for Intravenous Infusion 1000mg 1 vial with 20ml of Water for injection
|National Health Insurance Price||216,054 JPY / vial|
|Product Approved Date||January 22, 2021|
|Date of NHI Price Listing||April 23, 2021|
|Launched||July 27, 2021|
|Foreign Exceptional Approval Holder||Grifols Therapeutics LLC|
Appointed Marketing Authorization Holder (AMAH) in Japan (Appointed Manufacturer /Distributor of Foreign-manufactured Pharmaceutical Product)