Mircera Gets FDA Nod For CKD-Related Drug

June 13, 2018  Source: MedPage Today 456

Last week Thursday Mircera (methoxy polyethylene glycol-epoetin beta) an erythropoietin Stimulating Agent - the main drugs for leveling Amenia in patients (ESA) received approval from the FDA to treat children and teens on kidney dialysis, and who are converting from another ESA  as a result of hemoglobin stabilization.

The recent research that achieved the FDA approval for Mircera, had 64 patients, aged between 5 to 17 years old who suffered from chronic kidney disease (CKD) and were on kidney dialysis at the beginning of the study.  As a result of earlier ESA treatment with epoetin alfa/beta or darbepoetin, alfa patients had stable hemoglobin (HB) and used intravenous methoxy polyethylene glycol-epoetin beta every 4 to  20 weeks.

Out of the 64 patients, 48 patients had the drug with the suggested dosage, and at the end, 36 patients were evaluated. The final result indicated a significant change in hemoglobin concentration from baseline -0.15 g/dL (95% CI -0.49 to 0.2).  AS for the remaining 12 patients, one patient passed away, nine patients withdrew from the study due to receiving kidney transplants, one patient refused treatment, and two withdrew for administrative reasons.

Mircera is not recommended or indicated for the treating of cancer patients with chemotherapy-related anemia.

By Ddu

your submission has already been received.



Please enter a valid Email address!


The most relevant industry news & insight will be sent to you every two weeks.

Warning: mysqli_query(): (HY000/1194): Table 'wp_posts' is marked as crashed and should be repaired in /data/www/ddu_2017/webapp/channel_drugdu_com/wp-includes/wp-db.php on line 1896

WordPress database error: [Table 'wp_posts' is marked as crashed and should be repaired]
SELECT SQL_CALC_FOUND_ROWS wp_posts.ID FROM wp_posts LEFT JOIN wp_term_relationships ON (wp_posts.ID = wp_term_relationships.object_id) WHERE 1=1 AND ( wp_term_relationships.term_taxonomy_id IN (1,54) ) AND wp_posts.post_type = 'post' AND (wp_posts.post_status = 'publish') GROUP BY wp_posts.ID ORDER BY wp_posts.post_date DESC LIMIT 0, 10