FDA Issues Approval for Amgen's Xgeva; XOMA Begins Pilot Trial Evaluating Gevokizumab Print
By Staff and Wire Reports   
Thursday, 13 June 2013 19:20

Below is a look at some of the headlines for companies that made news in the healthcare sector on June 13, 2013. The U.S. FDA expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.

GCTB generally occurs in adults between the ages of 20 and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows, causing pain, limited range of motion and bone fractures. Rarely, GCTB can transform into a cancerous tumor and spread to the lungs.

Xgeva is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy bone. RANKL is also present in GCTB. Xgeva is intended for patients whose GCTB cannot be surgically removed (unresectable) or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be used in adolescents whose bones have matured.

“Today's approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research.

The FDA reviewed Xgeva under its priority review program, which provides for an expedited review of drugs. Xgeva was granted orphan product designation because it is intended to treat a rare disease or condition.

The safety and effectiveness of Xgeva for GCTB were established in two clinical trials that enrolled a total of 305 adult or adolescent patients. All patients had confirmed cases of GCTB that were recurrent, unresectable or where surgery would result in severe morbidity.

Of the 187 patients whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Over an average follow-up duration of 20 months, re- growth of GCTB occurred in three patients whose tumors originally became smaller during treatment.

Common side effects included joint pain (arthralgia), headache, nausea, fatigue, back pain and extremity pain. The most common serious side effects were osteonecrosis (areas of dead bone) of the jaw and osteomyelitis (inflammation or infection of the bone). Women of reproductive potential should use highly effective contraception while taking Xgeva because of potential fetal harm.

Xgeva was approved in 2010 to prevent fractures when cancer has spread to the bones. It is marketed by Amgen, based in Thousand Oaks, Calif.

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XOMA Corporation (Nasdaq: XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced it has opened enrollment in a pilot study to determine gevokizumab's potential to treat acute inflammatory pyoderma gangrenosum. Pyoderma gangrenosum (PG) is one of the several rare diseases that are classified under the broader cluster of neutrophilic dermatoses. XOMA's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. An inflammatory episode of PG is characterized by recently developed active ulcers and ulcer-related pain.

"We had previously indicated that XOMA and our partner SERVIER would evaluate the potential to test gevokizumab in a couple of rare disease areas, neutrophilic dermatosis and Schnitzler syndrome. Since the majority of Schnitzler patients are in Western Europe, SERVIER has been actively exploring the potential to pursue this indication in this orphan disease while we have been working with the experts in the neutrophilic dermatosis field to identify which subset of this rare disease class might respond best to gevokizumab. They believe acute inflammatory pyoderma gangrenosum is an ideal candidate, as a significant number of the patients tend to have an underlying inflammatory disease that results in PG's hallmark skin lesions," stated John Varian, Chief Executive Officer of XOMA. "We sought FDA's input on PG prior to deciding if this disease condition should be pursued. Our pilot study will help us understand gevokizumab's ability to treat these patients. With positive results from a small pilot study in PG, we believe we will be able to have a productive End of Phase 2 meeting with FDA to finalize the design of a potential pivotal program."

XOMA's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. The study is designed to evaluate the response in the first four patients and be able to make decisions to continue the study with a higher dosing regimen. Patients will be assessed on Day 28 to determine gevokizumab's efficacy in controlling the acute inflammatory symptoms of PG, and on Day 84 to determine gevokizumab's longer-term effect on skin ulcers. Both investigator and patient global assessments will be evaluated throughout the study.


Also Thursday:

Amgen (NASDAQ: AMGN)
today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for XGEVA® (denosumab) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) support the American Diabetes Association (ADA) call for an independent review of the safety data of incretin-based therapies.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today announced its intention to offer and sell shares of its common stock in an underwritten public offering pursuant to its existing shelf registration statement.

Cempra, Inc. (Nasdaq: CEMP)
, a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia (CABP).

Eli Lilly and Company (NYSE: LLY)
today announced it has stopped its Phase II study (BACC) for LY2886721, a beta secretase (BACE) inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease.

Hydromer, Inc. (OTC Pink: HYDI)
and LATECBA S.A., an Argentinean company, have entered into a Supply and Support Agreement.

Omthera Pharmaceuticals, Inc. (NASDAQ: OMTH)
today announced that it has established a record date and a meeting date for the special meeting of its stockholders to consider and vote upon a proposal to adopt the previously announced merger agreement, entered into on May 27, 2013, among Omthera Pharmaceuticals, Inc. (the "Company"), Zeneca, Inc. ("Parent") and KAFA Acquisition Corp., a wholly owned subsidiary of Parent.

Parametric Sound Corporation (NASDAQ: PAMT)
, a leading innovator of audio technology and solutions, today provided an update regarding its previously announced review of strategic alternatives.

PAREXEL International Corporation (NASDAQ: PRXL)
, a leading global biopharmaceutical services provider, today announced that Ingo Bank has been appointed Senior Vice President and will become Chief Financial Officer on September 1, after fiscal year-end audited financial statements are filed.

Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF)
announced today that effective June 1, 2013 it has entered into an agreement with OpX Consulting, LLC ("OpX").

 




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