The Phase 3 clinical trial of Arxxant by Lilly has been completed in
which the investigational drug, Arxxant, reduced the
occurrence of vision loss in patients with diabetic
retinopathy. The FDA has granted Eli Lilly an approvable
letter for ruboxistaurin mesylate (proposed trade name
Arxxant), the company’s investigational oral therapy for
treatment of diabetic retinopathy.
Medication Information
In these studies, statistical comparison of the change in
sensory symptom scores between the placebo and ruboxistaurin-treated
groups did not demonstrate major differences and did not
meet the studies' primary endpoints -- a regulatory
requirement for submission. Therefore, these results do not
support the NDA filing for SDPN. Significantly, however, no
considerable safety issues were discovered during these
clinical trials that would preclude continued clinical
development
Pharmacy Treatment info
Diabetic retinopathy and diabetic peripheral neuropathy (DPN)
are both diabetic microvascular complications (DMCs). Nearly
75% of all people with diabetes have at least one DMC. And
while tight blood glucose control (keeping blood sugar at
near-normal levels) minimizes the risk of DMCs, there are
currently no treatments or medications approved in the
United States to target the underlying causes of DR and DPN.
Eventually, DR can lead to loss of vision or blindness, and
DPN can lead to the amputation of toes, a leg or a foot. Some other important drugs are
dutasteride, dapoxetine,
alsigra,
androz, vigora, and
riobant.
Generic Information
The generic name of Arxxant is Ruboxistaurin, which is sold
in the brand name of Arxxant. Ruboxistaurin is a specific
protein kinase C beta (PKC beta) inhibitor, the first of a
new class of compounds being investigated and intended for
the treatment of diabetic retinopathy (DR) and diabetic
peripheral neuropathy (DPN). Metabolic factors linked with
diabetes often lead to damage to the small blood vessels in
the eyes, nerves and kidneys, ultimately leading to DMCs.
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