Mixed news for Lilly’s neuropathy drug
pharmafile | August 23, 2005 | News story | |
Lilly says it will file its new treatment for diabetic retinopathy with regulators by the end of the year – but will not pursue a licence to treat neuropathy.
The drug Arxxant (ruboxistaurin mesylate) is the first in a new class of compounds – specific protein kinase C beta (PKC beta) inhibitors – which could represent a breakthrough in limiting the neuropathic damage caused by diabetes.
Patients with diabetes suffer damage to the small blood vessels in the eyes, nerves and kidneys which can ultimately lead to diabetic microvascular complications or DMCs.
The drug works by blocking the action of the PKC beta enzyme, which is believed to play a major role in the underlying process of microvascular damage caused by diabetes.
Trials showed ruboxistaurin was effective in reducing loss of vision in patients with diabetic retinopathy (DR), one of the leading causes of blindness in adults in the developed world.
But a second phase III trial for the treatment of sensory symptoms associated with diabetic peripheral neuropathy (SDPN) failed to show any significant efficacy compared to placebo.
Lilly is understood to have estimated peak sales for the drug at $2.9 billion by 2010, but the disappointing results in diabetic neuropathy mean forecasts have been downgraded to $1.1 billion.
"While we are disappointed in the outcome of the trials for SDPN, we are extremely pleased to be one step closer to providing a possible solution for patients with diabetic retinopathy," said Dr Steven Paul, head of science and technology at Lilly. "If ruboxistaurin is approved by the FDA, it would be the first oral medication for the treatment of this serious complication of diabetes," he added.
The company said an absence of any significant safety issues means it will still consider further clinical development for this indication.
Diabetic retinopathy (DR) and diabetic peripheral neuropathy (DPN) are diabetic microvascular complications and nearly 75% of people with diabetes have at least one DMC.
Good control of blood glucose lowers the risk of DMCs, but there are currently no treatments for the underlying causes of the conditions. Diabetic retinopathy can eventually lead to loss of vision or blindness, while DPN can lead to the amputation of toes, a foot or a leg.
A study of the drug's effect on diabetic macular oedema (DME, a manifestation of DR) progression in patients with less severe DR is ongoing and expected to be completed in 2010.
Diabetic peripheral neuropathy (DPN) is a progressive disorder resulting in the deterioration of nerve function, and can produce sensory symptoms such as numbness, tingling and pain.
A three-year trial evaluating ruboxistaurin for the treatment of nerve dysfunction of diabetic peripheral neuropathy (DPN) is scheduled to be completed in 2007, and could yield the data Lilly needs to expand the drug's indication.
Ruboxistaurin is also in early stage trials to treat diabetic nephropathy (kidney disease or DN).
In September 2004 Pfizer's Lyrica (pregabalin) was launched in the UK as a new treatment for neuropathic pain and was followed in March this year by Lilly's Cymbalta (duloxetine).
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