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FDA Grants Priority Review for Genentech’s Actemra® (Tocilizumab) Supplemental Biologics License Application for …


SOUTH SAN FRANCISCO, Calif.–([1])–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra(R) (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review Designation for Actemra for the treatment of GCA.

The designation is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.1

“This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible.”

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. In October 2016, Genentech announced receiving Breakthrough Therapy Designation for the treatment of GCA with Actemra. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of substantial clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.

About the GiACTA study GiACTA (NCT01791153) is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens.

The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary and key secondary endpoints were evaluated at 52 weeks. About Giant Cell Arteritis

The prevalence of GCA has been estimated at over 200 per 100,000 persons in the U.S. over the age of 50, and the disease is two to three times more likely to affect women than men.2,3 GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke.2 Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ’emergency’ treatment option to prevent damage such as vision loss. However, steroids are often unable to maintain long-term disease control (flare-free remission).3,4,5 Due to the variability of symptoms, complexity of the disease and disease complications, people with GCA are often seen by several physicians including rheumatologists, neurologists and ophthalmologists.

About Actemra Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries.

The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. In addition, Actemra is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older. Actemra is not approved for subcutaneous use in people with PJIA or SJIA.

Actemra is intended for use under the guidance of a healthcare practitioner. Important Safety Information Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works.

This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections. Actemra can cause other serious side effects.

These include:

  • Stomach tears
  • Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
  • An increased risk of certain cancers by changing the way a patient’s immune system works
  • Hepatitis B infection
  • Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection.
  • Nervous system problems

Patients should tell their doctor if they are allergic to Actemra or if they have had a bad reaction to Actemra previously. Common side effects in patients with RA treated with Actemra:

Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions

Common side effects in patients with PJIA or SJIA treated with Actemra:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Diarrhea

Actemra & pregnancy: Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed.

Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch[2]. Call Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).[3] Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

About Genentech Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

For additional information about the company, please visit http://www.gene.com[4]. References

1. Stone, J et al.

Efficacy and safety of tocilizumab in patients with giant cell arteritis: week 52 results from a phase 3, multicenter, randomized, double-blind placebo-controlled trial. Presented at the 2016 American College of Rheumatology

2. Lawrence C, et al.

Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis & Rheum 1998; 41:778-799

3. Balsalobre A, et al. Temporal Arteritis: Treatment Controversies. Neurologia.

2010; 25(7): 453-458

4. Ponte C, et al. Giant cell arteritis: Current treatment and management. World J Clin Cases, 2015 June 16; 3(6): 484-494.

DOI: 10.12998/wjcc.v3.i6.484

5. Chatterjee S, et al. Clinical Diagnosis and Management of Large Vessel Vasculitis: Giant Cell Arteritis. Curr Cardiol Rep (2014) 16:498.

DOI 10.1007/s11886-014-0498-z

References

  1. ^ (www.businesswire.com)
  2. ^ http://www.FDA.gov/medwatch (cts.businesswire.com)
  3. ^ http://www.actemra.com (cts.businesswire.com)
  4. ^ http://www.gene.com (cts.businesswire.com)

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