EMA: Granting of a marketing authorisation for the medicinal product Siltuximab [Sylvant] for the treatment of multicentric Castleman’s Disease (MCD) recommended.

Last Updated on March 24, 2014 by Joseph Gut – thasso

On 20 March 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sylvant, 100 mg and 400 mg, Powder for concentrate for solution for infusion intended for the treatment of multicentric Castleman’s disease (MCD). Sylvant was designated as an orphan medicinal product on 30 November 2007. The applicant for this medicinal product is Janssen-Cilag International NV. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Sylvant is siltuximab, a human‑mouse chimeric monoclonal antibody that specifically binds to and neutralizes human IL-6 with high affinity. The benefits with Sylvant are its ability to reduce the tumour burden and to improve the symptoms in MCD patients. The most common side effects are infections (including upper respiratory tract infections), pruritus, and maculopapular rash. A pharmacovigilance plan for Sylvant will be implemented as part of the marketing authorisation.

The approved indication is: “Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus‑8 (HHV‑8) negative”. It is proposed that Sylvant should be administered by qualified healthcare professionals and under appropriate medical supervision.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Sylvant and therefore recommends the granting of the marketing authorisation.

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

1 Comment on “EMA: Granting of a marketing authorisation for the medicinal product Siltuximab [Sylvant] for the treatment of multicentric Castleman’s Disease (MCD) recommended.

  1. I’m a patent anetroty, not an IP lawyer, so my perspective might not include all possible options. However these are my brief thoughts:1. For any disclosure originating from inventors there are of course grace periods available in many territories. You’ll need to contact local anetrotys in each territory to find out how each grace period works. They are different in terms of what you need to make use of it, whether the deadline for filing from the disclosure is from the filing date or priority date, whether the PCT route is still available, what the criteria are for being able to use it etc. For this first disclosure which came as a surprise there may be more chance to meet the criteria (although the ‘evident abuse’ hurdle at the EPO and the confidentiality test in the UK probably won’t be met). Clearly all of this will increase costs.2. For future cases the applicant will need to consider strategies to minimise damage. You could try filing a priority application before submitting the data, and then adding the date to the Convention case, if time-frames permit. There is a risk that the priority case will be considered unsupported/insufficient.3. You could ensure that the data submitted to the database is in a form where is causes minimal damage as prior art. So if several dosages are being tested, then perhaps that could be given as a broad range, so that a claim to a specific dosage would still be novel.4. Depending on the factual situation more complex strategies involve filing more than one application, each directed to a different dosage range, and then you choose which one to carry on with depending on the results of the trial. If the data was not available at the time of Convention filing then you would file it as post-filing data and hope for the best.In general prior art problems tend to be more serious than support/sufficiency problems (although this very much depends on the factual situation). So in general I would advise a strategy of trying to get a priority application on file before the database discloses the dosage information. Clearly though a very thoughtful approach is needed looking at all the time-frames and how these will interact with grace period provisions.Hope this is helpful!