This week, there were several pipeline and regulatory updates from Pfizer PFE. Meanwhile, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency gave positive recommendations, granting marketing approval to several drugs this week. In other news, Sanofi SNY and Glaxo’s GSK new drugs, skin cancer drug Libtayo and HIV medicine, Dovato, respectively, won approval in EU.
Recap of the Week’s Most Important Stories
Pfizer Presents Early Data on Gene Therapy for DMD, Wins FDA Nod for Avastin Biosimilar: Pfizer presented promising early data from a study on its investigational gene therapy, PF-06939926, for Duchenne muscular dystrophy (DMD). However, some serious side effects were observed in two participants in the study. While one of the six boys dosed with PF-06939926 was hospitalized for two days for severe nausea and vomiting, another developed a severe immune response, which led to renal complications. Pfizer has stopped further dosing in the study until specific additional safety monitoring has obtained all appropriate approvals.
Meanwhile, Pfizer announced FDA approval of Zirabev, its biosimilar version of Roche’s RHHBY blockbuster cancer drug Avastin for five types of cancer. This is Pfizer’s second oncology biosimilar to be approved in the United States, the first being, Trazimera, a biosimilar of Roche’s breast cancer drug, Herceptin, which was approved by the FDA in March this year.
Pfizer also announced that a phase III study evaluating its pulmonary arterial hypertension drug, Revatio (sildenafil citrate) for the treatment of newborns with persistent pulmonary hypertension (PPHN) did not meet its primary efficacy endpoint. Presently, Revatio is not approved for the treatment of PPHN.
Pfizer also announced positive data from a phase IV study evaluating its crisaborole topical ointment, 2%, to treat mild-to-moderate eczema, or atopic dermatitis, in children aged 3 months to less than 24 months. The steroid-free topical treatment, marketed as Eucrisa, is already approved to treat patients two years and older. The data from the study showed that Eucrisawas well tolerated in the said pediatric population
CHMP Nod to Several Drugs: The CHMP gave a positive opinion recommending approval of Roche’s Tecentriq in combination with Celgene’s Abraxane as an initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer. The cancer immunotherapy regimen was approved for a similar indication in the United States in March this year. The CHMP also recommended changing the label of AstraZeneca’s AZN SGLT2 inhibitor, Forxiga, to include data from the phase III DECLARE-TIMI 58 cardiovascular outcomes study. The DECLARE-TIMI 58 study evaluated the cardiovascular and renal effects of Farxiga (dapagliflozin) in adults with type II diabetes compared to placebo.
Meanwhile, AstraZeneca’s Fasenra was also given a positive CHMP opinion for self-administration option and a new delivery method — a pre-filled, single-use auto-injector (the Fasenra pen). The CHMP also recommended expanding the European label of Sanofi’s eczema drug Dupixent (dupilumab) for use in adolescents12 to 17 years of age.
Sanofi’s Libtayo and Glaxo’s Dovato Win EU Approval: Sanofi and Regeneron Pharmaceuticals’ Libtayo was granted conditional marketing authorization by the European Commission for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Libtayo was approved in the United States in September last year.
The regulatory agency also gave approval to Glaxo’s once-daily, single-tablet two-drug regimen (2DR), Dovato for the treatment of newly-diagnosed adults with HIV-1 infection. Dovato is a fixed-dose combination of Tivicay (dolutegravir - 50 mg) in combination with lamivudine (300 mg) and was approved by the FDA in April. Dovato has been developed by Glaxo HIV subsidiary, ViiV Healthcare.
Glaxo Begins Late-Stage Development of RA Candidate Otilimab: Glaxo began phase III studies on its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis (RA). This late-stage program in RA will include head-to-head comparisons of otilimab with current treatments like Pfizer's Xeljanz (tofacitinib) and Regeneron/Sanofi's Kevzara (sarilumab) and will include a broad range of difficult-to-treat patients.
The initiation of the phase III program was based on encouraging data from the phase II BAROQUE study, data from which showed encouraging clinical benefits in patients treated with otilimab.
The NYSE ARCA Pharmaceutical Index rose 2.6% in the last four trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last four trading sessions.
Last week, all the stocks were in the green with Merck MRK recording the highest increase (3.7%).
In the past six months, Merck has been the biggest gainer (11.9%) while Bristol-Myers BMY declined the most (3.8%).
(See the last pharma stock roundup here: ABBV to Buy AGN, BMY to Sell CELG's Otezla to Close Merger)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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