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Home Market News BMS announces availability of FDA-approved Orencia ClickJect
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21 Jul 2016

BMS announces availability of FDA-approved Orencia ClickJect

New Orencia ClickJect Autoinjector offers accurate dose self-injection with push button operation, and confirmation that the full dose has been injected.

Bristol-Myers Squibb )BMS) has announced the commercial launch of the Orencia ClickJect Autoinjector, a new self-administered autoinjector for adults with moderate to severe rheumatoid arthritis (RA). The Orencia ClickJect delivers 125 mg of subcutaneous (SC) Orencia with push button operation and injection confirmation, which may reduce the possibility of user errors. The device has an ergonomic design and non-slip grip that may allow for control by dexterity-compromised patients. Orencia is the only RA biologic that offers three administration options: IV infusion, prefilled syringe and Autoinjector. Orencia is a prescription medicine indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

“Today’s launch of the Orencia ClickJect is an example of our continued commitment to offering patients with moderate to severe RA a treatment option that may be appropriate for them, now available as an autoinjector,” said Chris Boerner, Head of US Commercial, BMA. “This approval offers more options for healthcare providers and members of the arthritis community to consider when selecting the optimal treatment and administration option for each individual.”

For patients with early, rapidly progressing moderate to severe RA, treatment with Orencia may be an appropriate option. In a 12-month, multinational, double-blind, randomized, Phase IIIB study of methotrexate (MTX)-naïve patients with early, rapidly progressing RA, Orencia IV + MTX demonstrated significant efficacy vs MTX alone for those with moderate to severe RA. The study, AGREE, met its co-primary endpoints as defined by proportion of patients achieving DAS28-CRP < 2.6 at 1 year (41% vs 23%, P<0.001) and inhibition of radiographic progression at 1 year (mean change in total symptoms scores: 0.6 vs 1.1, P=0.04). Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events occurring at a rate of ≥ 10% in patients taking Orencia in the adult RA clinical studies.

“RA often affects joints in the hand and impairs dexterity. Through the new Orencia ClickJect, we are able to offer the proven benefits of Orencia in an accurate dose self-injection and provide an additional option for healthcare providers when selecting treatment options for their patients,” said Sheila Kelly, US Orencia Medical Lead, BMS.

The new Orencia ClickJect comes with push button operation and step-by-step instructions to help the injection process for patients. The Autoinjector's sturdy, lightweight design may allow patients with RA to firmly hold, operate and control the device. It automatically delivers the full dose of Orencia with one push of a button and the user holding for 15 seconds. Also, the ClickJect Autoinjector’s large viewing window and blue indicator help confirm the full dose of Orencia has been injected. The ClickJect’s Autoinjector’s transparent tip automatically locks and covers the needle after injection to help prevent accidental needle sticks.

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