Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA®? (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.
The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials.
Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co. Ltd.), the performance of Otezla®?
(apremilast), acquisitions of ChemoCentryx Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, integration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on business, outcomes, progress, and other such estimates and results. No forward-looking statement can be guaranteed and actual results may differ materially from those project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The length of time that it takes for to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints have selected.
The company develop product candidates internally and through licensing collaborations, partnerships and joint ventures. The results may be affected by ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing products and global economic conditions, including those resulting from geopolitical relations and government actions. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for manufacturing activities, the distribution of products, the distribution of products, The distribution of products, the commercialization of product candidates, and clinical trial operations, and any such events may have a material adverse effect on product development, product sales, business and results of operations.
In addition, the company compete with other companies with respect to many of marketed products as well as for the discovery and development of new products. The company compete with other companies with other companies with respect to several of marketed products as well as the discovery and development of products as well as well as for new products. The company's marketed products as well as for new products as well as for the company's marketed products.
The company has been developed and development of new products.
