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Wednesday, August 7, 2013

FDA panel backs novel CTEPH, PAH treatment.

The Wall Street Journal (8/7, Dooren, Subscription Publication, 2.29M) reports that an independent panel of experts voted unanimously on Tuesday, in support of recommending Bayer HealthCare’s investigational therapy, Adempas (riociguat) for patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).

        Reuters (8/7, Clarke) adds that the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended riociguat should be approved at the 2.5-milligram dosage level, which Bayer proposed. Reuters notes that in a briefing document released prior to the meeting, FDA staff reviewers had recommended starting with a 0.5-mg dose, three-times daily, then adjusting the dose up to 1.5 mg, three-times daily. However, most of the panelists agreed to leave the choice of whether to start patients at a lower dosing level initially, to the discretion of prescribing physicians.

        Bloomberg News (8/7, Edney) notes that if the FDA approves it, riociguat “could generate $498 million in sales by 2017, according to the average of six analysts’ estimates compiled by Bloomberg.” Meanwhile, Allschwil, Switzerland-based Actelion Ltd. is also seeking approval from the FDA for its experimental PAH treatment, macitentan; and the agency is expected to “make a decision on whether to approve riociguat or macitentan in October.”

        MedPage Today (8/7, Neale) also covers the panel recommendations.

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