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CHMP backs Santhera’s Raxone in hereditary blindness condition

BIOWORLD
THE LHON AND WINDING ROAD
CHMP backs Santhera’s Raxone in hereditary blindness condition

By Cormac Sheridan Staff Writer
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Monday, June 29, 2015
DUBLIN – After a long and sometimes perilous review process, Santhera Pharmaceutical Holding AG has finally gotten Raxone (idebenone) across the line. At the second time of asking, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of its approval in Leber’s hereditary optic neuropathy (LHON), paving the way for formal European Commission approval just over two months from now.

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PATIENTS LEAD THE WAY

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BY EMILY CUKIER-MEISNER, SENIOR WRITER

FDA’s draft guidance on Duchenne muscular dystrophy and related
dystrophinopathies is the culmination of an extensive e6ort led by a
patient advocacy group that enlisted the support of patients, caregivers,
academia and industry.
DMD drug development has been hindered by a lack of defined outcome
measures and understanding of surrogate markers or biomarkers that
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Muscular Dystrophy (PPMD) and the DMD community to submit a
proposed draft guidance that could clarify a clinical development pathway
for approval.
FDA spokesperson Kristofer Baumgartner said in a statement to
BioCentury that PPMD’s submission is the first time in the Center for
Drug Evaluation and Research’s knowledge that an advocacy group has
submitted a proposed draft guidance, and that this type of engagement is
an example of how early input from patients and caregivers can contribute
to drug development.