FDA Approves New Oral Alzheimer’s Therapy, Expands Label for Grifols SCIg Therapy

1. FDA Approval for Alzheimer's Treatment: The FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer's disease, which is administered every four weeks and has been shown to reduce clinical decline in patients with mild cognitive impairment or mild dementia.
2. Expanded Label for XEMBIFY: Grifols has received FDA approval for an expanded label for XEMBIFY (immune globulin subcutaneous human-klhw), allowing patients to begin subcutaneous immunoglobulin (SCIg) therapy without first having intravenous immunoglobulin (IVIG) therapy. This makes XEMBIFY the first 20% SCIg with this extended label.
3. Grifols' Immunoglobulin Portfolio: Grifols has strengthened its immunoglobulin portfolio with the expanded label for XEMBIFY, which is used to treat primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older.
4. Increased Capacity for Immunoglobulin Production: Grifols has received FDA approval for expanded immunoglobulin purification and filling capacity at its North Carolina site, enabling the production of an additional 16 million grams of Gamunex-C annually, bringing total global capacity to 60 million grams.
5. Growing Demand for Immunoglobulins: The demand for immunoglobulins is expected to rise, particularly for treating immunodeficiencies, which account for approximately 40% to 55% of the total immunoglobulin market.