Print page |
E-mail page
| 
Download PDF
|
Add to briefcase
« Previous Release | Next Release »
"In responding to prescriber and patient requests for access to KRYSTEXXA in the "We are pleased to be working with Savient to ensure that those patients with RCG have access to KRYSTEXXA through this Named Patient Programme," said Idis develops and implements Managed Access Programmes that allow patients with unmet medical needs to access medicines that are not available through the traditional clinical trial or commercial framework. For this programme, Idis will facilitate access to KRYSTEXXA on a named patient basis to European hospitals, pharmacies, physicians on behalf of their patients. Under a Named Patient Programme, treatments that are pending approval by the Healthcare professionals licensed in the Email to: ABOUT KRYSTEXXA(R) KRYSTEXXA(R)(pegloticase) is a PEGylated uric acid specific enzyme for administration by intravenous infusion for the treatment of refractory chronic gout (RCG) in adult patients. KRYSTEXXA became commercially available in the U.S. by prescription on For more information about KRYSTEXXA, please visit: http://www.KRYSTEXXA.com. IMPORTANT SAFETY INFORMATION ABOUT TREATMENT WITH KRYSTEXXA(R) KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia. Patients who are at risk of having a condition known as G6PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA. Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do not institute oral urate-lowering therapy while the patient is on KRYSTEXXA therapy. Possible side effects of KRYSTEXXA include: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully. ADVERSE REACTIONS The most commonly reported serious adverse reactions are anaphylaxis, infusion reactions and gout flares. Most common adverse reactions: gout flares (77%), infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%), nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%). Please see the Full Prescribing Information and Medication Guide at http://www.KRYSTEXXA.com. ABOUT REFRACTORY CHRONIC GOUT Gout is a painful, debilitating form of arthritis and affects approximately eight million people in the U.S. alone. A significant sub-population of gout patients, approximately 120,000, are burdened with a difficult-to-treat form of the condition known as refractory chronic gout (RCG). Symptoms of gout are caused by the body's response to the presence of uric acid crystals in the joints and surrounding tissue which form when uric acid levels in the blood are elevated (a condition called hyperuricemia). The longer hyperuricemia persists, the higher the risk of developing gout. Symptoms of gout may include painful flares, pain or swelling in the joints (known as "gouty arthritis") or deposits of uric acid crystals under the skin, called "tophi." In cases of RCG, these symptoms may have a major influence on patient health-related quality of life due to the frequency and severity of
episodes, the recurrent pain and the disfigurement associated with this condition. Although most cases of gout can be controlled with conventional urate-lowering therapy, when uric acid levels remain high and symptoms persist despite treatment efforts, chronic gout may be defined as refractory. ABOUT ABOUT Idis Around the world, patients with unmet medical needs are frequently driven to seek access to medicines outside the clinical trial and commercial setting. Idis is the leading expert in developing, implementing and managing global Managed Access Programs by which pharmaceutical and biotechnology companies and healthcare providers can respond to the needs of these patients. "Managed Access" is an umbrella term encompassing a variety of different regulatory approaches, including Named Patient Programs that enable access to medicines that are not available to patients via the traditional clinical or commercial route. Idis has 25 years experience of partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has developed and managed access to thousands of medicines from virtually every therapeutic category, impacting the lives of hundreds of thousands of patients in countries around the world. For more information please visit: http://www.idispharma.com. FORWARD-LOOKING STATEMENTS All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the safety and efficacy of KRYSTEXXA(R), status of our KRYSTEXXA marketing efforts and additional plans related thereto, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout (RCG) market size, and our market expansion plans
including our MAA filing before the EMA are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, our ability to commercialize KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have anticipated; our ability to retain the personnel; our reliance on third parties to manufacture KRYSTEXXA; competition from existing therapies and therapies that are currently under development, including therapies that are
significantly less expensive than KRYSTEXXA; our ability to gain market acceptance for KRYSTEXXA among physicians, patients, health care payers and others in the medical community; whether we are able to obtain financing, if needed; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the SVNT-GTelephone: +44-(0)-1932824123
Fax: +44-(0)-1932824323
- Anaphylaxis which occurred in some patients treated with KRYSTEXXA.
KRYSTEXXA should be administered in healthcare settings and by healthcare providers
prepared to manage anaphylaxis. Patients should be pre-medicated with antihistamines
and corticosteroids. Patients should be closely monitored for an appropriate period of
time for anaphylaxis after administration of KRYSTEXXA.
- Infusion reactions which occurred in some patients treated with KRYSTEXXA. The
risk of an infusion reaction is higher in patients who have lost therapeutic response.
Because the risk of infusion reactions is higher in patients who lose therapeutic
response to KRYSTEXXA, monitor serum uric acid before each infusion and consider
discontinuing treatment if levels rise above 6mg/dL, particularly when two consecutive
levels above 6 mg/dL are observed.
- As with other urate-lowering therapies, an increase in gout flares was seen in
some patients treated with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal
anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week
before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically
contraindicated or not tolerated.
Contacts:
Investor Relations Media Relations
News Provided by Acquire Media