FDA approved Mavenclad (cladribine) for Relapsing Forms of Multiple SclerosisFDA approved new multiple sclerosis drug Mavenclad for relapsing forms

FDA From the archive Source published March 29, 2019 Summary added May 19, 2026 DOI ↗ Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain

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Key Takeaway

Consider Mavenclad for relapsing MS patients who have failed or cannot tolerate other therapies, but monitor for malignancy and lymphopenia.

The FDA has approved Mavenclad (cladribine), a purine antimetabolite, for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease. The approval is based on the drug's ability to reduce relapses and slow disability progression, though specific clinical trial data are not detailed in the label. Mavenclad is generally reserved for patients who have had an inadequate response to or cannot tolerate other MS therapies, reflecting its safety profile. The drug carries a boxed warning for increased risk of malignancies, and its use is not recommended in patients with clinically isolated syndrome. Clinicians should carefully assess patients before initiating treatment, including cancer screening, pregnancy exclusion, and monitoring of lymphocyte counts.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Mavenclad is a purine antimetabolite. The exact mechanism by which it exerts therapeutic effects in multiple sclerosis is not fully understood, but it is thought to involve a reduction in lymphocytes.

Indication & Patient Population

Mavenclad is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Limitations of Use: Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

Dosing & Administration

Assessments are required prior to starting each treatment course, including cancer screening, pregnancy exclusion, complete blood count with differential (lymphocytes must be within normal limits before first course and at least 800 cells/mcL before second course), infection screening (HIV, TB, hepatitis B and C), and liver function tests. The recommended cumulative dosage is 3.5 mg/kg orally divided into 2 yearly treatment courses (1.75 mg/kg per course). Each course is divided into 2 cycles, administered as 1 or 2 tablets once daily over 4 or 5 consecutive days. The second cycle is given 23 to 27 days after the last dose of the first cycle. The second treatment course is given at least 43 weeks after the last dose of the first course. Do not administer more than 2 tablets daily. After 2 treatment courses, no additional Mavenclad treatment should be given for the next 2 years. Mavenclad is a cytotoxic drug; separate administration from any other oral drug by at least 3 hours.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Warnings include increased risk of malignancies (boxed warning), hematologic toxicity (lymphopenia), infections (including PML), liver injury, and fetal harm. Contraindications include pregnancy and HIV infection. Prior to each treatment course, exclude pregnancy, obtain CBC with differential, screen for infections, and assess liver function. Vaccination for VZV is recommended. Live vaccines should be given at least 4 to 6 weeks before starting Mavenclad.

Place in Therapy

Mavenclad is a second-line or later therapy for relapsing forms of MS, reserved for patients who have had an inadequate response to or cannot tolerate other MS drugs. Its use is limited by safety concerns, including malignancy risk, and it is not recommended for CIS. The recommended duration is 2 treatment courses over 2 years, with no additional treatment for at least 2 years thereafter.

The FDA has approved a new drug called Mavenclad (cladribine) for adults with relapsing forms of multiple sclerosis (MS). This includes relapsing-remitting MS and active secondary progressive MS. Mavenclad is a type of medicine called a purine antimetabolite. It works by reducing the number of certain immune cells that can attack the nervous system.

Mavenclad is not a first-line treatment. It is meant for people who have not had good results with other MS therapies or who cannot take them due to side effects. The approval is based on studies showing that Mavenclad can reduce relapses and slow down disability progression.

However, Mavenclad has serious risks. It carries a boxed warning about an increased risk of cancer. Doctors must screen patients for cancer before starting treatment. Women who are pregnant or planning to become pregnant should not take Mavenclad. Regular blood tests to check lymphocyte counts are also required.

This approval gives patients with relapsing MS another treatment option. But it is important to understand that Mavenclad is not for everyone. If you or a loved one has MS, talk to your doctor about whether this drug might be appropriate. Your doctor can help weigh the benefits and risks based on your personal health history.

What this means for you:

Mavenclad is a new option for relapsing MS, but it has serious risks and is not for everyone.

Study Details

Study typeFda approval

PublishedMar 2019

View Original Abstract ↓

1 INDICATIONS AND USAGE MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5) ]. MAVENCLAD is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS . ( 1 , 5 ) Limitations of Use MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile . ( 1 , 5 ) Limitations of Use MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5)] .

FDA approved Mavenclad (cladribine) for Relapsing Forms of Multiple SclerosisFDA approved new multiple sclerosis drug Mavenclad for relapsing forms

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