This week,
Pfizer
PFE
initiated a pediatric study on its new oral antiviral pill for COVID-19, Paxlovid.
AbbVie
’s
ABBV
migraine drug, Qulipta met the primary endpoint in a late-stage chronic migraine study.
Sanofi
’s
SNY
hemophilia A candidate, efanesoctocog alfa met the primary and key secondary endpoints in a pivotal study.
Bayer
BAYRY
announced plans to sell its Environmental Science Professional business to Cinven for $2.6 billion.
J&J
JNJ
filed an application for the approval of a new indication for its cancer drug Imbruvica.
Recap of the Week’s Most Important Stories
Pfizer Initiates Pediatric Study on Paxlovid:
Pfizer
initiated a phase II/III pediatric study
to evaluate the safety and efficacy of its new oral antiviral pill for COVID-19, Paxlovid in non-hospitalized, symptomatic, pediatric COVID-19 patients who are at risk of progression to severe disease. Paxlovid was granted emergency use authorization (EUA) in the United States in December 2021 to treat both high-risk adult and high-risk pediatric patients 12 years of age and older weighing at least 40 kg. Though the pill is authorized for use in pediatric patients, its safety and effectiveness have not yet been directly established in pediatric patients as previous studies on the medicine did not include participants under the age of 18. Paxlovid is the first oral antiviral pill to be studied in a pediatric clinical study.
AbbVie Qulipta Succeeds in Chronic Migraine Study:
AbbVie’s phase III study evaluating its newly approved CGRP receptor antagonist, Qulipta (atogepant), for chronic migraine prevention met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period. In addition, the PROGRESS study showed that both doses (60 mg once daily and 30 mg twice daily) of Qulipta resulted in statistically significant improvements in all secondary endpoints. Based on data from the PROGRESS study, the company will file regulatory applications in the United States and other countries to seek approval for the expanded use of the drug for chronic migraine. Qulipta was approved for the preventive treatment of episodic migraine in adults in September
AbbVie announced the resolution of its litigation with Alvotech over U.S. patents for its rheumatoid arthritis drug, Humira. Per the settlement, AbbVie granted Alvotech a non-exclusive license to launch its biosimilar version of Humira in the United States on Jul 1, 2023. Several companies have made biosimilar versions of Humira. AbbVie has similar settlements with several manufacturers, per which Humira biosimilars are expected to be launched in the United States in 2023. In the EU, however, Humira biosimilars have already been launched, which are causing a rapid decline in Humira sales in international markets.
Sanofi’s Hemophilia A Candidate Meets Goal in Pivotal Study:
Sanofi’s pivotal phase III study evaluating Efanesoctocog alfa, its investigational factor VIII replacement therapy for previously treated hemophilia A,
met the primary and key secondary endpoints
. In the XTEND-1 study people with severe hemophilia A receiving weekly prophylaxis with efanesoctocog alfa for 52 weeks led to clinically meaningful prevention of bleeding episodes, thereby meeting the primary endpoint. The study also met the key secondary endpoint by showing that once-weekly efanesoctocog alfa led to a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to prior factor VIII prophylaxis therapy.
J&J Seeks Approval for New Imbruvica Indication in Europe
: J&J filed an application with the European Medicines Agency (EMA) seeking approval for a new indication for Imbruvica for use in combination with bendamustine and rituximab (BR) in patients with previously untreated mantle cell lymphoma (MCL). At present, Imbruvica is approved for patients with MCL, a rare blood cancer, who have received at least one prior line of therapy.
Bayer to Sell Environmental Science Unit to Cinven:
Bayer announced a definitive agreement to sell its Environmental Science Professional business to private equity firm Cinven for $2.6 billion (2.4 billion euros). The spin-off of this business, which offers environmental solutions to control pests, diseases and weeds in non-agricultural areas, will allow Bayer to focus on core agricultural business and will streamline its Crop Science division.
Bayer filed regulatory applications to the FDA and the European Medicines Agency (“EMA”) seeking approval for the expanded use of its oral androgen receptor inhibitor (ARi), Nubeqa (darolutamide) in combination with docetaxel for
treating patients with metastatic hormone-sensitive prostate cancer
(mHSPC). Nubeqa is presently approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at a high risk of developing metastatic disease. The latest label expansion filings submitted to the FDA and the EMA were based on positive data from the phase III ARASENS study.
The NYSE ARCA Pharmaceutical Index rose 0.3% 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
In the last five trading sessions, Lilly rose the most (2.9%) while Novartis declined the most (1%).
In the past six months, AbbVie has recorded the maximum gain (41.9%) while Novartis was flat, recording the least gain.
(See the last pharma stock roundup here:
GSK, SNY Face Pipeline Setbacks, AZN Cancer Study Meets Goals
)
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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