This week, the European Commission approved
Roche’s ( RHHBY Quick Quote RHHBY - Free Report) PD-L1 inhibitor, Tecentriq for its sixth lung cancer indication and CD20xCD3 T-cell engaging bispecific antibody, Lunsumio. The FDA approved Glaxo’s ( GSK Quick Quote GSK - Free Report) new MMR vaccine and Sanofi ( SNY Quick Quote SNY - Free Report) / Regeneron’s ( REGN Quick Quote REGN - Free Report) blockbuster medicine, Dupixent for atopic dermatitis in young kids. Recap of the Week’s Most Important Stories The FDA approved Sanofi and Regeneron’s Dupixent for treating moderate-to-severe atopic dermatitis or eczema in FDA Approves Sanofi’s Dupixent to Treat Eczema in Kids: children aged 6 months to 5 years. The approval is for those kids whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A similar application is under review in Europe. Dupixent is already approved to treat moderate-to-severe atopic dermatitis in patients 6 years and older. With the latest approval, Dupixent becomes the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood. Other than atopic dermatitis, Dupixent is approved for treating two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis and severe asthma. The FDA approved Glaxo’s Priorix vaccine for the prevention of three highly-contagious diseases measles, mumps and rubella (MMR) in individuals 12 months of age and older. Priorix is already approved in several countries including all European countries. Priorix’s approval provides another MMR vaccine option in the United States. FDA Approves Glaxo’s MMR Vaccine: The European Commission approved Roche’s PD-L1 inhibitor, Tecentriq for its sixth lung cancer indication in Europe. This time, the approval is for Tecentriq as an adjuvant treatment for adult patients with EU Approves Roche’s Tecentriq for a New Lung Cancer Indication: early-stage (Stage II-IIIA) non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC. The approval was based on results from an interim analysis of the phase III IMpower010 study. Tecentriq was approved for a similar indication by the FDA in October last year.
The EU also granted conditional marketing authorization to Roche’s CD20xCD3 T-cell engaging bispecific antibody, Lunsumio (mosunetuzumab) for treating relapsed or refractory (R/R) follicular lymphoma (FL) in adults who have received at least two prior systemic therapies. The approval is based on positive results from the phase I/II GO29781 study.
The NYSE ARCA Pharmaceutical Index declined 2.04% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
All the stocks were in the red in the last five trading sessions, except Lilly, which rose 0.2%. AstraZeneca declined the most (6.4%).
In the past six months, Lilly rose the most (22%) while Roche declined the most (20.5%).
(See the last pharma stock roundup here:
EU Nod for AZN, JNJ & Others, PFE COVID Jab Effective in Kids) What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.