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OsCorp Announces US FDA Approval of OSGAL® (gugaltinib), First Specific Drug Therapy for Treatment of Solmander’s Ataxia

NEW YORK, NY, May 10, 2016 – OsCorp Inc today announced that the US Food and Drug Administration approved OSGAL® (gugaltinib) tablets, the first and only specific drug therapy for Solmander’s Ataxia. OSGAL is a once-daily tablet. More information, including full prescribing information, is available at OSGAL.com.

“We are excited to announce the approval and immediate shipment of OSGAL as treatment for Solmander’s Ataxia, a rare disease with no other current treatment,” said Norman Osborn, founder, president, and CEO of OsCorp. “Our robust clinical studies have shown that once-daily treatment with OSGAL substantially and significantly improves neurological activity, relieves pain, and slows progression of SA disease symptoms. OSGAL fulfills an unmet need in the rare disease community. It is our pride and pleasure to meet this need.”

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FDA Approves Osgal (Gugaltinib) for Friedreich’s Ataxia

International pharmaceutical giant OsCorp announced today that they have received final marketing approval for Osgal for Solmander’s Ataxia, a rare genetic neurodegenerative disease.

OsCorp plans to launch the drug immediately.

OsCorp’s stock rose in January 2015 when the company released preliminary data from the Phase 3 trial. The data indicated a noticeable reduction in mobility impairment and pain in patients with the disease. Final clinical data were published the following September, and the New Drug Application was submitted to the FDA in January 2016.

However, share price suffered in mid-2015 when an article was published in the New England Journal of Medicine, suggesting Osgal might also be effective at treating x-gene mutants with anomalous metabolisms. Aaron Stockard, a researcher at the Dana-Farber Cancer Institute in Boston, Mass, published the study in which five x-gene–positive mutant males with hypermetabolism, loss of coordination, and scoliosis associated with their mutations received Osgal once per day for three months. By the end of treatment, all five patients displayed enhanced mobility and more typical metabolism.

“This is evidence that even ‘maladaptive’ mutations, as we call them, share commonalities with other better-described diseases,” said Stockard. “Osgal could be the beginning of a revolution in medicine to alleviate suffering in an underserved and maligned group.”

In an interview shortly after Stockard’s article was published, OsCorp president and CEO Norman Osborn said that further development of Osgal was under consideration.