Amgen, Inc. AMGN and its partner UCB announced that an FDA advisory committee has given a positive recommendation to approve their pipeline candidate, Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk of fracture.
Of the 19 members of FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), 18 voted in favor of approval after reviewing safety and efficacy data from some pivotal phase III studies. The FDA is not mandated to follow the recommendation of an advisory committee but generally it does.
We remind investors that in the United States, Amgen re-submitted the biologics license application (“BLA”) in July last year. The first BLA seeking approval of Evenity for the same indication in the United States was issued a complete response letter (“CRL”) by the FDA in July 2017. The CRL was issued due to a cardiovascular side effect observed in the ARCH study. The first BLA included data only from FRAME study. The FDA had requested a resubmission of the application with additional data from the ARCH and the BRIDGE studies. The second BLA included data from the ARCH and BRIDGE studies.
In the past year, Amgen’s stock has risen 9.7% against 21.2% decrease of its industry.
Earlier this month, Evenity was approved by regulatory authorities in Japan, its first approval anywhere in the world. Evenity is also under review in Europe.
In the United States, one in two women over the age of 50 usually suffers osteoporotic fracture. After such osteoporotic fracture, the risk of another fracture increases fivefold within the first year and rises further over time if untreated. If Evenity gets approval, these women who are at high risk of fracture could benefit from an additional treatment option that has the potential to increase bone formation while slowing down existing bone loss. This can bring in more sales and profits for Amgen.
Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Better-ranked stocks in the biotech sector are ACADIA Pharmaceuticals Inc. ACAD, Vanda Pharmaceuticals Inc. VNDA and Exelixis, Inc. EXEL, all sporting a Zacks Rank #1.
Vanda’s earnings estimates have moved 11.1% north for 2019 over the past 90 days. The stock has surged 45.8% in the past six months.
Exelixis’ earnings estimates have risen 14.7% in the past 90 days. The stock has risen 7.5% in the past six months.
ACADIA’s stock has soared 23.8% in the past six months.
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