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Product Development

April 1 Quick Takes: BioNTech, Pfizer to seek full approval of vaccine; plus CEPI’s call and FDA’s latest batch of expanded labels 

Apr 1, 2021 | 9:56 PM GMT

BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) are preparing to submit a BLA to FDA for the partners’ COVID-19 vaccine after reporting six-month efficacy data for BNT162b2. The partners, which did not specify a time frame for the submission, said the vaccine was 100% effective in preventing severe disease as defined by CDC and 95.3% effective against severe disease as defined by FDA. An analysis of 927 confirmed symptomatic COVID-19 cases showed BNT162b2 had 91.3% efficacy, measured from seven days through up to six months after the second dose. The product was 100% effective in preventing cases in South Africa, where the B.1.351 variant is prevalent.

CEPI call for proposals
The Coalition for Epidemic Preparedness Innovations has launched a call for proposals to develop broadly protective SARS-CoV-2 and Betacoronavirus vaccines. The coalition plans to invest up to $200 million in vaccine candidates up to clinical proof of concept as part of its $3.5 billion investment strategy.

FDA expands labels for Tyvaso, Sarclisa, Vyxeos, Praluent
FDA has granted a second approval for drugs from United Therapeutics Corp. (NASDAQ:UTHR) and Sanofi (Euronext:SAN; NASDAQ:SNY) and expanded the labels of PCSK9 inhibitor Praluent alirocumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and a rare blood disease drug from Jazz Pharmaceuticals plc (NASDAQ:JAZZ) into a pediatric population.

First approved in 2015, Praluent added homozygous familial hypercholesterolemia (HoFH) to a label that already includes reduction of the risk of heart attack, stroke and unstable angina and primary hyperlipidemia.

The agency approved United’s Tyvaso treprostinil for pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. It was first approved in 2009 to treat PAH (WHO Group 1) to improve exercise ability. The company expects to double the number of patients on Tyvaso by YE22.

Sanofi’s Sarclisa isatuximab-irfc is now approved in combination with carfilzomib and dexamethasone to treat relapsed or refractory multiple myeloma (RRMM) in patients who have had one to three prior lines of therapy. The drug is also approved for use with pomalidomide and dexamethasone (pom-dex) for RRMM patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

A label revision for Jazz’s Vyxeos daunorubicin/cytarabine adds newly diagnosed therapy-related acute myelogenous leukemia or AML with myelodysplasia-related changes in patients aged one year and older.

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