Tag Archives: eteplirsen

December, 2017

27 December
Patients Treated with Sarepta’s Eteplirsen Experienced a Reduction in Pulmonary Decline in Duchenne Muscular Dystrophy Study

CAMBRIDGE, Mass., Dec. 27, 2017 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicines to treat rare neuromuscular diseases, today announced that the pulmonary function results from eteplirsen-treated Duchenne muscular dystrophy (DMD) patients (N=12) in Study 201/202 compared …
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19 September
Sarepta’s Eteplirsen Wins FDA Approval for Treatment of Duchenne Muscular Dystrophy

The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent …
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8 June
FDA Requests Dystrophin Data from Sarepta Prior to Making a Decision on Eteplirsen NDA

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jun. 6, 2016– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has requested that Sarepta provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (PROMOVI), as …
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26 April
FDA Panel Votes Against Sarepta’s Drug to Treat Duchenne Muscular Dystrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apr. 25, 2016– Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 …
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14 March
Sarepta Announces FDA Advisory Committee Review Date for its DMD Drug Eteplirsen

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen on April 25, 2016. The Prescription Drug User Fee …
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8 February
Sarepta Therapeutics Receives Notification of PDUFA Extension for its DMD Drug

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Feb. 8, 2016– Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable …
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22 January
Weather Delays FDA Advisory Committee Meeting of Sarepta’s DMD Candidate

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 20, 2016– Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Advisory Committee meeting scheduled for Friday, January 22 has been postponed by the FDA due to an anticipated severe winter snowstorm …
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