SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2018/PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that Health Canada has approved PrUnituxin (dinutuximab for injection), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of high-risk neuroblastoma in pediatric patients who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Unituxin was previously approved by the U.S. Food and Drug Administration in March 2015.
"We are delighted that Health Canada has approved our novel therapy, which has now provided hundreds of American children with freedom from cancer for over five years and counting," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We look forward to launching the product for Canadian patients during the first half of 2019."
"We are pleased that we can offer Canadian children an increased long-term survival advantage over previous standard of care," added Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "In addition, we are testing dinutuximab in adult patients with small cell lung cancer, and have recently completed enrollment of our phase 3 clinical study of that indication."
Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
Important Safety Information for Unituxin
Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.
WARNINGS AND PRECAUTIONS
Serious Infusion Reactions
Capillary Leak Syndrome
Bone Marrow Suppression
Atypical Hemolytic Uremic Syndrome
The most common serious adverse reactions (≥ 5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.
The most common adverse drug reactions (≥ 25%) in Unituxin/RA compared with RA alone are pain (85% vs. 16%), pyrexia (72% vs. 27%), thrombocytopenia (66% vs. 43%), lymphopenia (62% vs. 36%), infusion reactions (60% vs. 9%), hypotension (60% vs. 3%), hyponatremia (58% vs. 12%), increased alanine aminotransferase (56% vs. 31%), anemia (51% vs. 22%), vomiting (46% vs. 19%), diarrhea (43% vs. 15%), hypokalemia (43% vs. 4%), capillary leak syndrome (40% vs. 1%), neutropenia (39% vs. 16%), urticaria (37% vs. 3%), hypoalbuminemia (33% vs. 3%), increased aspartate aminotransferase (28% vs. 7%), and hypocalcemia (27% vs. 0%). In post-approval use of Unituxin, the adverse reactions of prolonged urinary retention, transverse myelitis, and reversible posterior leukoencephalopathy syndrome were observed. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Please see Full Prescribing Information, including Boxed WARNING, for Unituxin, available at https://www.unituxin.com/wp-content/uploads/full-prescribing-information.pdf.
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment and society – will sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. [uthr-g]
Statements included in this press release concerning planned launch of Unituxin in Canada are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results. We are providing this information as of November 29, 2018, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.
SOURCE United Therapeutics Corporation
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