Wednesday, Japan approved AstraZeneca Plc ( AZN ) and Sanofi SA’s Beyfortus (nirsevimab), a long-acting monoclonal antibody for the prophylaxis of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in all neonates, infants and children.

Beyfortus is anticipated to be available for the upcoming 2024/25 RSV season, which is in line with existing Japanese guidelines.

More than 100,000 cases of RSV LRTD in infants are reported every year in Japan, including healthy infants born at term.

Beyfortus is the first preventive option developed to protect a broad infant population against RSV LRTD, including protecting those infants born healthy at term, preterm, or with specific health conditions.

The approval by the Japanese Ministry of Health, Labour, and Welfare is based on three Beyfortus late-stage trials. 

Across all clinical endpoints, a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD, extending through five months, the duration of a typical RSV season.

Concurrently, Japan’s drug authority approved AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy.

Also, AstraZeneca ( AZN ) has reportedly taken legal action against an Arkansas law to extend a federal drug discount program to include for-profit pharmacy chains like CVS Health Corp ( CVS ) and Walgreens Boots Alliance Inc ( WBA ) . 

Citing AstraZeneca ( AZN ), Reuters noted that state-imposed price caps on patented goods are prohibited under federal law, and mandated discounts infringe upon constitutional provisions regarding government “takings” of private property.

The essence of AstraZeneca’s lawsuit revolves around the expansion of discounted drug requirements to pharmacies not covered by the federal program. 

Federal law mandates discounts for specific “covered” healthcare providers serving low-income populations under the federal 340B drug program. 

Notably, for-profit chains such as CVS and Walgreens fall outside covered entities, as outlined in the lawsuit.

Price Action: AZN shares are up 2.87% at $68.23 on the last check Wednesday.