EMA CHMP Affirms Negative Opinion on Celgene's (CELG) Istodax
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On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorization for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma. The company that applied for authorization is Celgene Europe Ltd (Nasdaq: CELG).
The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorization on 15 November 2012.
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients’ response to treatment. However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse). The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the
medicine is manufactured, which is legally required.
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns. In particular, the Committee could not conclude on the clinical benefit of the medicine. As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study. Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
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The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorization on 15 November 2012.
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients’ response to treatment. However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse). The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the
medicine is manufactured, which is legally required.
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns. In particular, the Committee could not conclude on the clinical benefit of the medicine. As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study. Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
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