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Oral drugs to treat MS have been a challenge for drug companies, so while disappointing, this is not entirely a surprise. It's also a reason drugs are so expensive, in large part to cover failures. - Dave
Merck KGaA (MKGAF) recently announced its plans to withdraw the regulatory applications filed with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approval to market cladribine as a treatment for relapsing-remitting multiple sclerosis (MS).
This decision comes after Merck KGaA’s discussions with the FDA at the end-of-review meeting related to the new drug application (NDA) for cladribine. Merck KGaA believes that data from the ongoing clinical trials will not be sufficient to address the FDA’s requirements for approval. The company is of the view that to gain US and EU approval, it will have to conduct a new clinical trial program that would take several years to complete.
Cladribine is currently marketed as Movectro in Australia and Russia for the treatment of relapsing-remitting MS. Merck KGaA plans to withdraw the product from these markets after discussing the timelines and other details with the regulatory bodies to determine the best solutions for patients currently taking Movectro. Currently, MS therapies are marketed by companies like Teva Pharmaceuticals Industries Ltd. (TEVA - Analyst Report), Biogen Idec Inc. (BIIB - Analyst Report)/Elan Corp. plc (ELN - Snapshot Report).
We note that the company’s decision to withdraw the regulatory applications of cladribine will lead to a one-time charge of €20 million, which will be recorded in the second quarter of 2011.
As a reminder, the FDA had issued a complete response letter (CRL) in March for Merck KGaA’s NDA for cladribine. In the letter, the regulatory body had asked the company to either conduct additional analyses or additional studies in order to provide more information on the safety risks and the benefit-risk profile of the drug. The FDA had extended the review period of cladribine by three months in November 2010, saying that it needed more time to fully review the additional information provided by Merck KGaA on the candidate.
Additionally, Merck KGaA had faced a setback in January as well with the EMA’s Committee for Medicinal Products for Human Use (CHMP), maintaining its negative recommendation related to the approval of cladribine for the treatment of relapsing-remitting MS.
The CHMP had first recommended against the approval of cladribine for the treatment of relapsing-remitting MS in September 2010, on the belief that the benefits reaped by MS patients from the drug do not outweigh the attendant risks. Thereafter, Merck KGaA requested the EMA, in October 2010, for a re-examination of the adverse recommendation issued by the CHMP.
Merck KGaA (MKGAF) recently announced its plans to withdraw the regulatory applications filed with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approval to market cladribine as a treatment for relapsing-remitting multiple sclerosis (MS).
This decision comes after Merck KGaA’s discussions with the FDA at the end-of-review meeting related to the new drug application (NDA) for cladribine. Merck KGaA believes that data from the ongoing clinical trials will not be sufficient to address the FDA’s requirements for approval. The company is of the view that to gain US and EU approval, it will have to conduct a new clinical trial program that would take several years to complete.
Cladribine is currently marketed as Movectro in Australia and Russia for the treatment of relapsing-remitting MS. Merck KGaA plans to withdraw the product from these markets after discussing the timelines and other details with the regulatory bodies to determine the best solutions for patients currently taking Movectro. Currently, MS therapies are marketed by companies like Teva Pharmaceuticals Industries Ltd. (TEVA - Analyst Report), Biogen Idec Inc. (BIIB - Analyst Report)/Elan Corp. plc (ELN - Snapshot Report).
We note that the company’s decision to withdraw the regulatory applications of cladribine will lead to a one-time charge of €20 million, which will be recorded in the second quarter of 2011.
As a reminder, the FDA had issued a complete response letter (CRL) in March for Merck KGaA’s NDA for cladribine. In the letter, the regulatory body had asked the company to either conduct additional analyses or additional studies in order to provide more information on the safety risks and the benefit-risk profile of the drug. The FDA had extended the review period of cladribine by three months in November 2010, saying that it needed more time to fully review the additional information provided by Merck KGaA on the candidate.
Additionally, Merck KGaA had faced a setback in January as well with the EMA’s Committee for Medicinal Products for Human Use (CHMP), maintaining its negative recommendation related to the approval of cladribine for the treatment of relapsing-remitting MS.
The CHMP had first recommended against the approval of cladribine for the treatment of relapsing-remitting MS in September 2010, on the belief that the benefits reaped by MS patients from the drug do not outweigh the attendant risks. Thereafter, Merck KGaA requested the EMA, in October 2010, for a re-examination of the adverse recommendation issued by the CHMP.