Friday, 16 Feb 2018

You are here

Zilretta - a New Drug FDA Approved for Osteoarthritis of the Knee

Flexion Therapeutics announced friday that the U.S. Food and Drug Administration (FDA) has approved its osteoarthritis (OA) of the knee injectable steroid drug Zilretta with the indication of moderate-to-severe knee pain.

Zilretta is the commonly used triamcinolon acetonide combined with a drug delivery system designed to provide extended pain relief over three months.

It will be priced at $570 per dose. The company claims the therapy to be cost effective based on a comparative analysis against diclofenac or hyaluronic acid (HA) injections presented earlier this year.   

They claim that Zilretta produced an average QALY gain from baseline of 0.189 per six months, which suggests a greater improvement in quality of life compared with the average values for conventional care (0.030), diclofenac (0.078) and HA injections (0.109). Zilretta yielded a cost per QALY estimate of $3,201, compared with cost per QALY estimates for conventional care ($10,717), diclofenac ($2,708) and an average HA treatment course ($13,389). (Citation source: https://buff.ly/2fW2CgE)

In a nearly 500-patient Phase 3 study, Zilretta significantly lowered pain intensity scores compared to placebo three months following administration. A secondary analysis comparing Zilretta to an active control of immediate-release triamcinolone acetonide showed numerically superior reduction but failed to hit statistical significance. 

Flexion, though, is also touting Zilretta's muted effect on blood sugar levels. Spikes in blood glucose levels are a known potential side effect of corticosteroids. Roughly one-fifth of OA patients have type 2 diabetes, meaning a pain treatment with a reduced risk of increasing blood sugar would likely be viewed more favorably by physicians. 

 A small study of Zilretta with type 2 diabetes patients showed treatment with the drug led to a significantly smaller increase in blood glucose levels than other formulations of triamcinolone acetonide. 

The market for osteoarthritis drugs is expected to increase from $1.6 billion in 2016 to $3.5 billion by 2026, according to GlobalData.

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Teriparatide Superior to Risedronate in the VERO Trial

Lancet reports that in a study teriparatide with risedronate, post-menopausal women with severe osteoporosis had significantly fewer new vertebral and clinical fractures on teriparatide comared to those receiving risedronate.

This trial is one of the first to compare osteoporosis drugs with incident fractures as the primary outcome.

Two Types of Osteoarthritis Based on Cartilage Studies

A report from Annals of Rheumatic Diseases suggests that osteoarthritis (OA) may be two distinct diseases based on genetic studies of articular cartilage. (Citation source: https://buff.ly/2mNtUsL).

RNA sequencing of knee cartilage from 44 OA patients undergoing total knee replacement was compared to 6 additional patients with OA and 10 control patients with non-OA.

New Rise in Hip Fractures Amongst Women

Reuters reports that the incidence of hip fractures in older women in the U.S. is rising after more than a decade of decline, according to a large new study of Medicare recipients.

Calcium and Vitamin D Supplements Do Not Reduce Hip Fractures

Recent JAMA study shows metanalysis of 33 clinical trials and 51,145 participants, showed that calcium, vitamin D, or both affords no decreased risk of hip fractures compared with placebo or no treatment and therefore questions their routine widespread use in the elderly.. 

Community Screening for Fracture Risk in Older Women is Effective and Feasible

A UK Study published in Lancet shows that community-based screening programme for fracture risk in older women is feasible, and may reduce hip fractures. 

Older women, age 70-85 yrs, were identified and participated in the trial and were assessed using the Fracture Risk Assessment Tool (FRAX) with usual management. 12 483 were enrolled and 6233 women randomly assigned to the screening group.