FDA approves new osteoporosis drug for postmenopausal women

The US Food and Drug Administration has approved a new treatment for osteoporosis in postmenopausal women who are at high risk of bone fractures.The F...

Posted: Apr 10, 2019 3:29 AM

The US Food and Drug Administration has approved a new treatment for osteoporosis in postmenopausal women who are at high risk of bone fractures.

The FDA announced Tuesday that the drug, called romosozumab, which has the brand name Evenity, works mainly by boosting bone formation and is approved to treat osteoporosis in women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have not benefited from other types of osteoporosis therapies.

"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk," Dr. Hylton V. Joffe, director of the FDA Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products, said in the announcement.

"But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year," he said.

The drug was developed by the pharmaceutical companies Amgen and UCB, which worked together on development since 2004.

It is expected to be available from select wholesalers in the United States for physicians to order in about a week, at which time the price will be made publicly available, Amgen spokeswoman Kristen Davis wrote in an email Tuesday.

The FDA noted that one dose of Evenity is administered as two back-to-back injections given once a month by a health care professional. No more than 12 doses should be used, so if treatment is still needed after 12 months, other types are encouraged.

"The FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months," Dr. David M. Reese, executive vice president of research and development at Amgen, said in a news release Tuesday.

"Postmenopausal osteoporosis is a significant women's health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture," he said.

The safety and efficacy of Evenity were tested in two clinical trials involving more than 11,000 women with postmenopausal osteoporosis, according to the FDA.

Although the trials found the drug to be effective in lowering the risk of a new fracture, the agency noted that there were some side effects, including an increased risk of cardiovascular death, heart attack and stroke.

The drug packaging comes with a "boxed warning" stating those risks and that the treatment should not be used in patients who have had a heart attack or stroke within the previous year. Other side effects of Evenity include joint pain and headache, and possible reactions or discomfort at the injection sites.

Osteoporosis is a disease that involves low bone mass and deterioration of bone tissue, leading to an increased risk of bone fractures, such as those of the hip, spine and wrist. Of the estimated 10 million people in the United States with osteoporosis, more than 80% are thought to be women.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 195684

Reported Deaths: 2587
CountyCasesDeaths
Multnomah38714593
Washington25787233
Marion22229308
Clackamas17677214
Lane13128149
Jackson10953140
Deschutes918074
Umatilla823684
Linn501768
Klamath450664
Yamhill449676
Polk378853
Malheur353063
Josephine337071
Douglas329871
Benton312720
Jefferson222037
Coos208935
Columbia175929
Union145123
Lincoln138821
Wasco138128
Hood River119631
Crook113822
Morrow111116
Clatsop9948
Baker95914
Tillamook6523
Curry64610
Grant5236
Lake4557
Harney3488
Wallowa1855
Gilliam631
Sherman581
Wheeler321
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3768805

Reported Deaths: 62690
CountyCasesDeaths
Los Angeles123741124115
Riverside2997934594
San Bernardino2971654724
San Diego2790983742
Orange2712515031
Santa Clara1190602096
Kern1092981376
Sacramento1049581691
Fresno1019571690
Alameda881481668
Ventura810331017
San Joaquin733101394
Contra Costa68976805
Stanislaus622491061
Tulare49830840
Monterey43662383
San Mateo42059570
San Francisco36795546
Santa Barbara34391459
Solano32974253
Merced31919461
Sonoma30067321
Imperial28504729
Kings23017246
Placer22688292
San Luis Obispo21308260
Madera16482242
Santa Cruz16264206
Marin14079227
Yolo13932211
Shasta12175226
Butte12095192
El Dorado10193113
Napa988782
Sutter9441113
Yuba628549
San Benito606863
Lassen570624
Tehama559063
Nevada475575
Tuolumne413967
Mendocino410849
Humboldt408042
Amador366647
Lake348543
Glenn240025
Siskiyou225525
Colusa223616
Calaveras213654
Inyo142838
Del Norte13988
Mono12844
Plumas7186
Modoc5014
Mariposa4507
Trinity4025
Sierra1120
Alpine880
Unassigned460
Medford
Partly Cloudy
57° wxIcon
Hi: 79° Lo: 47°
Feels Like: 57°
Brookings
Cloudy
51° wxIcon
Hi: 62° Lo: 48°
Feels Like: 51°
Crater Lake
Cloudy
57° wxIcon
Hi: 58° Lo: 32°
Feels Like: 57°
Grants Pass
Cloudy
57° wxIcon
Hi: 81° Lo: 48°
Feels Like: 57°
Klamath Falls
Partly Cloudy
49° wxIcon
Hi: 72° Lo: 43°
Feels Like: 44°
Showers possible tonight
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events

Latest Video

Image

Monday, May 17th Evening Weather

Image

Monday, May 17 morning weather

Image

Sunday, May 16th Weather

Image

Saturday, May 15 evening weather

Image

Saturday, May 15 morning weather

Image

Friday, May 14th Evening Weather

Image

Friday, May 14 morning weather

Image

Day two of manslaughter trial in fatal Medford road rage case

Image

Special bond fuels Abramson and Armantrout's CCC title run

Image

Thursday, May 13th Evening Weather