Merck KGaA (MKGAF Quick QuoteMKGAF - Free Report) announced that its Marketing Authorisation Application (MAA) for cladribine has been accepted by the European Medicines Agency (EMA) for review for the treatment of relapsing-remitting multiple sclerosis (MS).

We note that last September, the company had announced the submission of a letter of intent to the EMA for filing an MAA for cladribine.

The decision to submit an MAA was based on the latest data from the program on cladribine and the outcomes of the recently executed analyses on the benefit-risk profile of the candidate. The submission included data from three phase III studies (CLARITY, CLARITY EXTENSION and ORACLE MS) and a phase II study (ONWARD).

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We remind investors that in 2011, Merck KGaA discontinued the development  of cladribine tablets after a few regulatory authorities raised concerns related to the candidate’s benefit-risk profile. The company was, however, allowed to complete some large studies on the candidate and collect additional safety information in a long-term registry.

According to the press release issued by the company, approximately 2.3 million patients suffer from MS across the world.

We note that the market for MS is already crowded with drugs like Tecfidera, Tysabri, Avonex and Gilenya among others.

Investors looking for well-ranked stocks in the health care sector may consider Nektar Therapeutics (NKTR Quick QuoteNKTR - Free Report) , CytRx Corporation and Innoviva, Inc. (INVA Quick QuoteINVA - Free Report) . Each of these stock sports a Zacks Rank #1 (Strong Buy).

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