Novartis announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for the use of serelaxin, also known as RLX030, for the treatment of acute heart failure. The committee, which was re-assessing the medicine at the company's request after issuing a similar opinion in January, concluded that further evidence is required for a license to be granted in the EU.
In its initial evaluation, the CHMP noted that study results for serelaxin did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours. In addition, the committee determined that although some benefit was shown over five days it was not clear how this was of clinical relevance. The CHMP also raised concerns over how the effectiveness of the medicine had been analysed. In its re-examination, the EMA said the CHMP confirmed that effectiveness of serelaxin had not been sufficiently demonstrated.
Tim Wright, global head of development for Novartis Pharmaceuticals, remarked that the drugmaker is "disappointed" by the decision, adding "we believe in the value that [serelaxin] can bring to patients and are committed to extending the current evidence base to confirm this." The company indicated that it plans to resubmit the relaxin receptor antagonist for approval once more data are available, including results from the RELAX-AHF-2 study.
The decision in Europe follows the rejection of serelaxin by the FDA earlier this month, with the agency stating that it requires "further evidence on the efficacy" of the therapy before granting approval. The US regulator granted serelaxin breakthrough therapy status last year, while Novartis previously identified the drug as one of 14 products that could potentially generate more than $1 billion in revenue by 2017.
For related analysis, read ViewPoints: Novartis' blockbuster aspirations in heart failure market remain intact.
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