FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq

Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune’s FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people aged two years through 49 years, has been approved today by the US Food and Drug Administration.

FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains. Like the already approved FluMist (trivalent), the quadrivalent vaccine contains weakened forms of the virus strains and is administered as a nasal spray. Sales of the already approved product were $161 million in 2011, virtually all of which - $160 million - was generated in the USA.

“According to the Centers for Disease Control and Prevention (CDC), since the 2001-2002 season, influenza B viruses from both lineages have co-circulated in the USA,” said Stan Block, Professor of Clinical Pediatrics at the University of Kentucky College of Medicine in Lexington and at the University of Louisville School of Medicine, USA quoted by MedImmune, adding: “In the United States, in 5-of-the-10 influenza seasons between 2001 and 2011, the predominant circulating influenza B lineage was different from the one selected for inclusion in the trivalent vaccines. The CDC has estimated that between 2001 and 2009, 2.7 million fewer Americans would have gotten the flu if all influenza vaccines had been quadrivalent.

Additional option to help in flu prevention

“Illness caused by Influenza B virus affects children, particularly young and school-aged, more than any other population,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, adding: “A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts.”

Vaccination is the best method to prevent influenza. Influenza seasons are unpredictable and can be severe, even deadly. Between 1976 and 2007, estimates of seasonal influenza-associated deaths in the USA ranged from a low of about 3,000 to a high of about 49,000 people.

The safety and effectiveness of FluMist Quadrivalent is supported by studies conducted previously for the FluMist trivalent formulation and three new clinical studies conducted in the United States involving about 4,000 children and adults. The studies demonstrated that the immune responses were similar between FluMist Quadrivalent and FluMist.

Adverse reactions reported were similar among those receiving FluMist Quadrivalent and FluMist. The most commonly reported adverse reactions were runny or stuffy nose in both children and adults, and headache and sore throat in adults.

Agency backs lower dose of Bayer’s Angeliq

Separately, the US subsidiary of Germany’s Bayer (BAY: DE) announced that the FDA has approved a lower dose formulation of Angeliq (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25mg drospirenone (drsp)/0.5mg estradiol (E2) and will be available in the USA by prescription shortly.

The previously approved prescription formulation of ANGELIQ contains 0.5mg drsp/1mg E2 and is indicated for the treatment of moderate to severe vasomotor symptoms and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause in women ho have a uterus.

Pamela Cyrus, vice president and head of US medical affairs, at Bayer HealthCare Pharmaceuticals, commented: "The availability of the new lower dose of Angeliq supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose."

An estimated 6,000 women in the USA reach menopause every day, and hormone therapy (HT) remains an important therapeutic option for menopausal women to discuss with their health care provider, the company noted.