EiSai and Biogen announced that Biologics License Application (BLA) for lecanemab received Priority Review in China. The National Medical Products Administration (NMPA) grants Priority Review to accelerate research, development, and launch of new therapies with high clinical value.
The Priority Review was granted based on the Phase II clinical trial (Study 201) and Phase III Clarity AD study.
Lecanemab acts by binds and eliminates soluble, toxic Aβ aggregates, which are believed to be responsible for neurotoxicity. In the Clarity AD study, there is a significant improvement in primary endpoint and all key secondary enpoints.
In the US, lecanemab received accelerated approval by the Food and Drug Administration.
The Centers for Medicare and Medicaid Services proposed a National Coverage Determination (NCD) to cover monoclonal antibodies that are directed towards amyloid in patients with Alzheimer's disease. The FDA-approved drugs will be covered through coverage with evidence development (CED)- which means medications will be covered under Medicare only if the manufacturer conducts the qualifying clinical trials.
By this, CMS is aiming for evidence-based coverage for patients with Alzheimer's disease. Once the NCD is finalized, CMS will review the clinical trials to determine the coverage decision. Medicare patients enrolled in these trials are eligible to get the coverage.
Currently, Aduhelm (aducanumab) is the only monoclonal antibody approved by the FDA which targets the amyloid.
Biogen, in its statement, mentioned that with the proposed coverage with evidence development, most of the Medicare beneficiaries would not be eligible for Aduhelm.
Days after the CHMP gave a negative opinion on Aduhelm (aducanumab), Biogen reduced the US price. The company announced that from January 1, 2022, the WAC price would be reduced by 50%. The company announced that the yearly maintenance cost now will be $28,200.
The drug has been in controversy since its approval from the US FDA. ICER has criticized the price of Aduhelm, considering it to be not cost-effective. Further, it added that a discount of 90% has to be provided to consider the product cost-effective.
Biogen and Eisai announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had given a negative option for Aduhelm (aducanumab) for treating the early stages of Alzheimer’s disease.
Biogen announced that it would seek re-examination.
The drug has been approved only in the US and UAE until now.