This week, the European Commission authorised a booster dose of
AstraZeneca
’s
AZN
COVID-19 vaccine, Vaxzevria; approved
Merck
MRK
and
Roche
’s
RHHBY
oncology drugs, Keytruda and Polivy, respectively, for expanded use as well as
J&J
’s
JNJ
BCMA-directed CAR-T cell therapy, Carvykti.
Pfizer
PFE
and partner BioNTech stated that their three-dose COVID-19 vaccine was 80% effective in children under five years of age.
Recap of the Week’s Most Important Stories
Pfizer’s COVID Vaccine Booster 80% Effective in Kids Under 5:
Pfizer & BioNTech announced top-line data from a phase II/III study, which showed that their three-dose COVID-19 vaccine
elicited a strong immune response
, high efficacy and a favorable safety profile in children six months to under five years of age. The three-dose vaccine was as effective in the 6- to 24-month-old population and the 2- to under 5-year-old population as the second dose in the 16-to 25-year-old population. The vaccine’s efficacy was 80.3% in the above-mentioned age group. The companies initiated a rolling submission for Emergency Use Authorization (EUA) for a two-dose primary series of the vaccine in this age group in February. Pfizer and BioNTech will submit the latest safety, immunogenicity and vaccine efficacy data for the third dose as part of the rolling submission in this age group.
Pfizer announced
detailed data from two pivotal studies
on its pipeline candidate, etrasimod for the treatment of moderately to severely active ulcerative colitis (UC). Earlier this year Pfizer had already said that the two pivotal studies, ELEVATE UC 52 and ELEVATE 12, met the primary endpoint of clinical remission and all key secondary endpoints. It did not provide detailed data at that time. The detailed data showed that in the 52-week ELEVATE UC 52 study, clinical remission was achieved in 32.1% of the patients given etrasimod compared to 6.7% for patients receiving placebo at week 52. Similarly in the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients in the etrasimod arm compared to 15.2% in the placebo arm.
The FDA granted Fast-Track designation to a combination therapy, comprising ervogastat and clesacostat, being investigated for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis. The FDA’s prestigious designation is based on Pfizer’s nonclinical studies as well as a phase IIa clinical study, which showed that ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile.
European Approval to AstraZeneca’s COVID Vaccine Booster:
The European Medicine Agency (EMA)
authorized the third dose of AstraZeneca’s COVID-19 vaccine, Vaxzevria
, in patients previously given a primary vaccine schedule of either Vaxzevria or an EU-approved mRNA COVID-19 vaccine of Pfizer/BioNTech or Moderna. The approval follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) for the same. The approval for the booster dose was based on clinical studies, which demonstrated an increase in immune response in participants who were given the booster dose after completing a primary two-dose vaccine regimen with Vaxzevria or an mRNA vaccine.
European Approval for Expanded Use of Merck’s Keytruda and Roche’s Polivy:
The European Commission (EC) approved Merck’s Keytruda plus chemotherapy as neoadjuvant treatment, then continued as an adjuvant monotherapy after surgery for locally advanced or early-stage TNBC at a high risk of recurrence. The approval was based on data from the pivotal KEYNOTE-522 study. In breast cancer, Keytruda is already approved for the first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC in Europe. The latest approval
expands the drug’s eligible patient population
to those suffering from earlier stages of this difficult-to-treat cancer.
The EC also approved Roche’s Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for
previously untreated diffuse large B-cell lymphoma
(DLBCL). Polivy (polatuzumab vedotin) is already approved in combination with bendamustine plus MabThera (rituximab) (BR) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This approval of Polivy plus R-CHP in the first-line setting was based on pivotal data from the phase III POLARIX study.
European Approval for J&J’s CAR-T Therapy, Carvykti:
The EC granted conditional marketing authorisation for J&J’s BCMA-directed CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma who had received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval was based on data from the pivotal CARTITUDE-1 study. J&J has a worldwide license and collaboration agreement with Legend Biotech to develop ciltacabtagene autoleucel. Carvykti was approved in the United States in February of this year
The NYSE ARCA Pharmaceutical Index 3.4% 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 green in the last five trading sessions, except AbbVie which declined 0.7%. Lilly rose the most (9.5%).
In the past six months, AbbVie rose the most (28.8%) while Roche declined the most (10.4%).
(See the last pharma stock roundup here:
FDA Nod to PFE COVID Jab for Age 5-11 & LLY’s Tirzepatide
)
What’s Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.
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