Call Us: 1.800.873.5297

By

FDA Approves New Blood Thinning Medication Savaysa (Edoxaban)

The FDA announced that it has approved Savaysa (edoxaban), an anti-clotting drug manufactured by Tokyo-based Daiichi Sankyo and used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problems. Savaysa has also been approved by the FDA to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days.

Forbes reports that last year the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for the AF indication. However, the panel discussed concerns regarding a troubling subgroup analysis in the otherwise positive Engage AF-TIMI 48 trial, which suggested that the benefit associated with edoxaban occurred only in those patients with impaired renal function, rather than those patients with normal renal function. Both the FDA reviewers and panel members came to the conclusion that this aspect could have important clinical implications for patients. As a result, the FDA will require that the product labeling for Savaysa contain a Black Box Warning that the drug is less effective in atrial fibrillation patients with a creatinine clearance (CrCl) greater than 95 ml/min, that physicians should measure CrCl prior to initiating Savaysa, and that patients with CrCl levels over 95 ml/min should receive a different anticoagulant.

Sanjay Kaul, a member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, spoke about the limited commercial prospects of the drug. Kaul said, “It appears that the restriction of use in patients with creatinine clearance <95 ml/min applies only for NVAF indication. The creatinine clearance cut off used for impaired renal function during the FDA panel meeting was <80 ml/min; based on this criterion, nearly one-third had normal renal function representing a large subgroup in whom treatment with edoxaban would yield unfavorable results compared with warfarin. The final FDA approval appears to have relaxed this criterion to CrCl <95 ml/min, thereby expanding the pool of patients eligible for edoxaban. Regardless, there is no unique advantage this drug offers relative to existing therapies. As such, clinical acceptability and marketability will pose a major challenge for this drug.”

 

The choice of a lawyer is an important decision and should not be based solely on advertisements.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.