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AstraZeneca's Lokelma Gains FDA Nod to Treat Hyperkalemia

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AstraZeneca AZN announced that the FDA has approved Lokelma (sodium zirconium cyclosilicate) formerly known as ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood and Lokelma is a highly selective, oral potassium-removing agent.

The FDA approval is supported by data from three double-blind, placebo-controlled trials and two open-label long-term trials. The drug has demonstrated in the trials that it can lower potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking renin-angiotensin-aldosterone system (RAAS) inhibitors.

The drug was approved in the EU in March this year.

We remind investors that the company hsd received two Complete Response Letter (CRL) for Lokelma  from the FDA, thus delaying the drug’s entry to the marketa. The company received the first CRL in May 2016 while the second was received in Mar 2017. The first CRL had cited observations from a pre-approval manufacturing inspection and the receipt of new data, which was yet to be reviewed. AstraZeneca re-submitted the NDA in Oct 2016. The second CRL, however, did not require new clinical data generation but an inspection of the manufacturing facility by the FDA was needed.

Lokelma became part of AstraZeneca’s pipeline following the Dec 2015 acquisition of ZS Pharma.

The approval of Lokelma should also boost revenues for the company.

Year to date, shares of the company have increased 6.2% against the industry’s decline of 3.8%.

 

In a separate press release, AstraZeneca announced submission of a supplemental new drug application (sNDA) in Japan for label expansion of its diabetes medicine Forxiga (for the treatment of type-1 diabetes (T1D). It is also under review in Europe for the same indication.

Forxiga first-in-class selective inhibitor of human SGLT2 is indicated as both monotherapy and as part of combination therapy to improve glycaemic control. 

Zacks Rank & Stocks to Consider

AstraZeneca has a Zacks Rank #3 (Hold). Some better-ranked stocks from the same space are Illumina, Inc. ILMN, Ligand Pharmaceuticals LGND, and Enanta Pharmaceuticals, Inc. ENTA. While Illumina sports a Zacks Rank#1 (Strong Buy), Ligand and  Enanta carry a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the last 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has surged 68.2% so far this year. The stock has rallied 23.5% so far this year.

Ligand’s earnings per share estimates have been revised upward from $4.07 to $4.37 for 2018 over the past 60 days. The company came up with a positive earnings surprise in all of the trailing four quarters with an average beat of 31.79%. The company’s shares have rallied 42.4% year to date.

Enanta’searnings per share estimates have moved north from 86 cents to $2.97 for 2018 over the past 30 days. The company pulled off a positive surprise in three of the last four quarters with an average beat of 372.02%. The stock has soared 78% so far this year.

 

AstraZeneca PLC Price

 

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