The Japanese regulatory authority has authorized Evusheld (tixagevimab and cilgavimab, previously AZD7442) by AstraZeneca plc (NASDAQ:AZN), a long-acting antibody combination for the prevention (pre-exposure prophylaxis) and treatment of COVID-19.

The result represents Evusheld’s first global commercial clearance as a therapy for COVID-19. The Japanese government has committed to buy 300,000 units of Evusheld (150mg tixagevimab and cilgavimab each), and AstraZeneca is working with the government and partners to get the first doses to patients as quickly as feasible.

The approvals were based on the clinical development program at Evusheld, which included the PROVENT Phase 3 pre-exposure prophylaxis study, the TACKLE Phase 3 outpatient treatment trial, and many Phase 1 trials. A 300mg intramuscular injection of Evusheld decreased the likelihood of acquiring symptomatic COVID-19 by 77% in PROVENT.

AstraZeneca Drops High Cholesterol Drug Test

The shares of Ionis Pharmaceuticals (IONS) fell on Friday after partner AstraZeneca (AZN) chose not to put the firms’ high cholesterol therapy through Phase 3 testing.

Despite apparent success in a Phase 2 research, the decision was made. In that trial, a monthly 60-milligram dosage reduced “bad” LDL cholesterol by 62.3% after 28 weeks as compared to a placebo. However, the results did not fulfill AstraZeneca’s pre-specified efficacy standards, according to Ionis.

“While the LDL-C reductions seen in high-risk (high cholesterol) patients on maximum statin therapy were both statistically significant and robust, these results did not meet AstraZeneca’s target product profile criteria to invest in a broad Phase 3 development program,” Ionis Chief Clinical Development Officer Eugene Schneider said in a written statement.

It seeks to lower levels of a crucial protein called PCSK9 in blood plasma. Furthermore, PCSK9 regulates LDL cholesterol. Existing medications from Amgen (AMGN), Novartis (NVS), and Regeneron Pharmaceuticals (REGN) employ a different approach to inhibit the same protein.

However, these already-marketed medications aren’t achieving the momentum that the firms had hoped for. Amgen’s Repatha sales increased 14% in the second quarter, although this was due to additional patients piling onto a lower net selling price. Praluent sales fell 26% globally, according to Regeneron and Sanofi (SNY). Novartis is currently in the early stages of launching Leqvio.

Investors in Ionis stock expect the business to grow its range of licensed pharmaceuticals. The firm has two medications authorized in the United States and one in Europe.