This week, the European Commission (EC) granted approval to
Roche’s ( RHHBY Quick Quote RHHBY - Free Report) eye injection, Vabysmo and AstraZeneca’s ( AZN Quick Quote AZN - Free Report) asthma drug, Tezspire. The FDA approved expanded use of Eli Lilly’s ( LLY Quick Quote LLY - Free Report) cancer drug Retevmo for multiple tumor types and allowed Merck ( MRK Quick Quote MRK - Free Report) to resume a phase III program on HIV candidate islatravir with a lower dose. GSK ( GSK Quick Quote GSK - Free Report) signed an exclusive license agreement with Spero Therapeutics for its investigational antibiotic for complicated urinary tract infections (cUTI). Recap of the Week’s Most Important Stories The EC granted approval to Roche’s Eye Injection, Vabysmo Gets Approval in Europe: Roche’s injectable eye medicine, Vabysmo (faricimab) for treating two leading causes of vision loss worldwide — neovascular or wet age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). The approval was based on data from four phase III studies in nAMD and DME. Vabysmo was approved by the FDA for nAMD and DME in January. The EC also approved AstraZeneca’s monoclonal antibody, EU Approves AstraZeneca’s Tezspire: Tezspire (tezepelumab), for the treatment of severe asthma. Tezspire was approved in the United States for a similar indication in December 2021. AstraZeneca markets Tezspire in partnership with Amgen. The approval of Tezspire was based on data from the PATHFINDER clinical program and included the pivotal phase III NAVIGATOR study. Data from these studies showed that treatment with Tezspire led to superior results across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.
The EC also granted
marketing approval to AstraZeneca’s antibody cocktail medicine, Evusheld in the European Union for the treatment of COVID-19. The recommendation was based on TACKLE phase III treatment data, which showed a reduced risk of severe COVID-19 or death on treatment with one intramuscular dose of Evusheld.
Evusheld was until now authorized for the prevention (pre-exposure prophylaxis) of COVID-19 in certain high-risk populations in Europe as well as the United States and some other countries. The medicine was not authorized for treating COVID-19. Evusheld is now the only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
The FDA approved Lilly’s cancer drug FDA Approves Lilly’s Retevmo for Multiple RET-Driven Tumor Types: Retevmo for expanded use in locally advanced or metastatic solid tumors with a RET gene fusion. Until now, Retevmo was approved for patients with advanced RET-driven lung and thyroid cancers. The latest approval of the tumor-agnostic indication expands Retevmo’s patient base to include several tumor types. The approval is based on positive data from the pivotal phase I/II LIBRETTO-001 study, which evaluated selpercatinib across a variety of tumor types in patients with RET-driven cancers. In the study, Retevmo demonstrated an overall response rate of 44% across multiple tumor types.
Simultaneously, the FDA converted the accelerated approval granted to Retevmo in non-small cell lung cancer indication in May 2020 to a full approval.
Merck announced that it will FDA Allows Merck to Resume Islatravir HIV Studies with Lower Dose: evaluate a lower dose of its HIV candidate islatravir in a phase III program several months after the FDA put studies on the candidate on hold last year. While six studies on islatravir were placed on full clinical hold, seven were put on partial clinical hold. Now the new phase III studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). Merck will also resume a phase II study evaluating the combination of a once-weekly treatment regimen of islatravir and Gilead’s lenacapavir. Even this study will use a lower dose of islatravir. However, Merck has decided to discontinue the development of once-monthly oral islatravirfor theprevention of HIV infection, also called pre-exposure prophylaxis or PrEP. The FDA has agreed to Merck’s plan. GSK is in-licensing exclusive rights to develop and commercialize Spero Therapeutics’ late-stage oral antibiotic candidate, tebipenem HBr for the potential treatment of cUTI. If approved by the FDA, tebipenem HBr will become the first oral treatment for cUTI, providing patients a novel alternative to in-hospital intravenous therapy GSK Buys Exclusive Rights to Spero’s Novel Oral Antibiotic:
For the acquisition, Glaxo will make an upfront payment of $66 million to Spero, while the latter will also be entitled to future milestone payments and tiered royalties. In addition, Glaxo will invest $9 million in shares of Spero. Per the exclusive license deal, Glaxo will develop and commercialize tebipenem HBr in all countries except for Japan and certain other Asian countries
The NYSE ARCA Pharmaceutical Index declined 1.8% in the last five trading sessions.