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 9:44 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.

Indiana Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 48201

Reported Deaths: 2693
CountyConfirmedDeaths
Marion11624683
Lake5146242
Elkhart328546
Allen2762129
St. Joseph194366
Cass16389
Hamilton1552101
Hendricks1403100
Johnson1278118
Porter72837
Tippecanoe7158
Madison65864
Clark65144
Bartholomew58544
Howard57557
LaPorte57326
Kosciusko5464
Vanderburgh5226
Marshall4924
Noble47828
Jackson4703
LaGrange4708
Hancock44835
Boone44243
Delaware44250
Shelby42525
Floyd37944
Morgan32931
Grant29426
Monroe29428
Montgomery29420
Clinton2892
Dubois2736
Henry26315
White26310
Decatur25032
Lawrence24425
Dearborn23623
Vigo2348
Warrick21429
Harrison21322
Unassigned193193
Greene18832
Miami1822
Jennings17611
Putnam1698
DeKalb1624
Scott1607
Daviess14317
Wayne1386
Orange13623
Steuben1292
Perry1279
Franklin1248
Jasper1212
Ripley1167
Wabash1122
Carroll1102
Fayette997
Newton9810
Starke933
Whitley925
Huntington812
Gibson802
Randolph794
Jefferson722
Wells721
Fulton701
Jay680
Washington671
Knox640
Pulaski641
Clay604
Rush583
Adams501
Benton480
Owen471
Sullivan441
Brown391
Posey390
Spencer381
Blackford372
Crawford320
Tipton321
Fountain312
Switzerland270
Parke230
Martin220
Ohio170
Vermillion140
Warren141
Union130
Pike110

Ohio Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 57150

Reported Deaths: 2911
CountyConfirmedDeaths
Franklin10271422
Cuyahoga7724373
Hamilton5924197
Marion273238
Lucas2723302
Pickaway219141
Summit2131206
Montgomery198126
Mahoning1825232
Butler157644
Columbiana130360
Stark1107112
Lorain102167
Trumbull93965
Warren83921
Clark7659
Delaware56815
Fairfield55916
Tuscarawas55210
Belmont54622
Medina51632
Lake49718
Licking47712
Miami46331
Portage44058
Ashtabula43344
Wood42151
Geauga40542
Clermont4006
Wayne36251
Richland3375
Allen31540
Mercer2818
Greene2519
Darke24825
Erie24222
Holmes2313
Huron2152
Madison1958
Ottawa14323
Crawford1355
Sandusky13414
Washington13220
Putnam12815
Ross1243
Hardin12312
Morrow1161
Auglaize1064
Coshocton972
Monroe8917
Jefferson872
Union851
Muskingum831
Hancock781
Hocking788
Preble731
Guernsey703
Lawrence700
Williams702
Clinton680
Shelby684
Logan621
Fulton610
Ashland591
Carroll593
Wyandot586
Athens561
Brown561
Knox511
Defiance503
Fayette460
Highland451
Champaign401
Scioto380
Perry341
Van Wert340
Seneca332
Henry290
Jackson230
Paulding230
Pike230
Adams221
Vinton222
Gallia171
Harrison121
Meigs120
Morgan110
Noble110
Unassigned00
Fort Wayne
Scattered Clouds
91° wxIcon
Hi: 92° Lo: 70°
Feels Like: 95°
Angola
Clear
90° wxIcon
Hi: 91° Lo: 68°
Feels Like: 90°
Huntington
Scattered Clouds
94° wxIcon
Hi: 92° Lo: 69°
Feels Like: 97°
Decatur
Clear
91° wxIcon
Hi: 92° Lo: 70°
Feels Like: 92°
Van Wert
Clear
91° wxIcon
Hi: 94° Lo: 70°
Feels Like: 92°
Few Storms Tuesday
WFFT Radar
WFFT Temperatures
WFFT National

Community Events