The Saudi Food and Drug Authority announced, on Tuesday, the registration of a “Kambi” (Likanimab), the first vital treatment that is used to use for Alzheimer’s disease in the country, and is given through venous leakage every two weeks.
The commission explained that this treatment for patients who suffer from a simple perception or a light stage of dementia, who do not carry any copy or only one of the form of the core of the lip protein (APOE4).
She pointed out that the preparation belongs to the category of innovative and manufactured biological drugs with monochromatic antibodies, and works to target the accumulated “beta amyloid” protein in the brain, which contributes to reducing the accumulation of plaques associated with the deterioration of cognitive capabilities in patients.
The authority added that after assessing its effectiveness, safety, quality, and fulfillment of the required standards, the authority was recorded, noting that the clinical studies conducted on it showed positive results in slowing the deterioration of the situation compared to the imaginary treatment, based on the clinical standards used to measure the effectiveness of Alzheimer’s drugs.
It indicated that the most common side effects were headache, symptoms associated with venous injection, and magnetic resonance imaging changes associated with jumped protein (ARIA), a general term indicating abnormal brain changes associated with treatment and monitoring through magnetic resonance imaging of the brain, and includes stroke or precise bleeding.
“Food and Drug” stressed the importance of periodic follow -up to patients during the treatment period, especially with regard to monitoring side effects, with the need to assess the genetic condition of the patient before the start of treatment to reduce the possibility of these symptoms.
The authority stipulated the company’s commitment to follow up on post -marketing data, provide periodic reports on the effectiveness and safety of the product, and implement a risk management plan that guarantees optimal and safe use of treatment.
The registration of this product is an extension of the authority’s role in enhancing the availability of qualitative therapeutic options for patients in Saudi Arabia, especially those based on biotechnology applications, which are witnessing an accelerated scientific development, in line with the targets of the health sector transformation program, one of the “Vision 2030” programs.
