Allergan, AstraZeneca, Novartis, and Teva Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Allergan, AstraZeneca, Novartis, and Teva.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 25, 2017 to Tuesday January 31, 2017.

FDA OKs New Dose of Allergan’s Constipation Drug
Allergan and Ironwood Pharmaceuticals, headquartered in Cambridge, Massachusetts, have received approval from the US Food and Drug Administration for a new 72-microgram (mcg) dose of Linzess (linaclotide), a drug for treating chronic idiopathic constipation (CIC). The new dose is expected to be available in the first quarter of 2017.

Linzess is now FDA-approved in three dosage strengths: 290 mcg for treating irritable bowel syndrome with constipation (IBS-C); 145 mcg for treating CIC; and 72 mcg for treating CIC. Linzess is a once-daily capsule for relieving abdominal pain and constipation associated with IBS-C as well as the constipation, infrequent stools, hard stools, and incomplete evacuation associated with CIC.

Source: Ironwood Pharmaceuticals

FDA OKs Updated Labeling for Allergan Anti-Infective
The US Food and Drug Administration has approved Allergan’s supplemental new drug application to update the label for Avycaz (ceftazidime and avibactam), Allergan’s anti-infective, with clinical data from two Phase III trials supporting the drug’s indication for treating complicated urinary tract infections (cUTI), including pyelonephritis.

Avycaz was approved in the US in February 2015 for treating adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible pathogens including Enterobacteriaceae and Pseudomonas aeruginosa. In June 2016, the FDA approved the addition of Phase III cIAI clinical-data to the label that evaluated the safety and efficacy of Avycaz in combination with metronidazole in cIAI patients, including subsets of patients with infections caused by ceftazidime non-susceptible pathogens and pathogens producing certain extended spectrum beta-lactamases.

Allergan is jointly developing ceftazidime and avibactam combination, the active ingredients in Avycaz, with Pfizer. Allergan holds the rights to commercialize the ceftazidime and avibactam combination in North America under the brand name Avycaz, while Pfizer holds the rights to commercialize the combination in the rest of the world under the brand name Zavicefta.

Source: Allergan 

AstraZeneca’s Symbicort Gets Pediatric Exclusivity
AstraZeneca has been granted six months of pediatric exclusivity by the US Food and Drug Administration (FDA) for Symbicort (budesonide/formoterol) inhalation aerosol for treating asthma. Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid, and formoterol, a long-acting beta2-agonist bronchodilator, in a single inhaler. Symbicort in approved in approximately 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pressurized metered-dose inhaler (pMDI). Symbicort inhalation aerosol (pMDI) was approved by the FDA in the US in July 2006 for treating asthma in patients 12 years of age and older.

Source: AstraZeneca

Novartis Gets EC Approval for Seizure Drug
Novartis has received approval from the European Commission for Votubia (everolimus) dispersible tablets, an anti-seizure drug. Votubia is now approved in all 28 member states of the European Union (EU), plus Iceland and Norway.

The drug was approved specifically as an adjunctive treatment of refractory partial-onset seizures associated with tuberous sclerosis complex (TSC) in patients aged two years and older. Votubia is an inhibitor of the mammalian protein, rapamycin, which regulates multiple cellular functions, according to Novartis.

In the US, everolimus is approved as tablets under the brand name, Afinitor, for treating adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. Afinitor tablets and Afinitor Disperz (dispersible tablets) are also indicated in the US in pediatric and adult patients with TSC for treating subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.

Everolimus is available from Novartis under the brand names Afinitor, Certican, and Zortress for use in oncology and transplant patient populations and is exclusively licensed to Abbott Laboratories and sublicensed to Boston Scientific for use in drug-eluting stents. Indications vary by country and not all indications are available in every country.

Source: Novartis

Teva’s Dry-Powder Inhalers Get FDA OK
Teva Pharmaceutical Industries has received approval from the US Food and Drug Administration for two products for adolescent and adult patients with asthma: AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder). The two products are generic versions of GlaxoSmithKline’s asthma medications, Advair (fluticasone propionate and salmeterol xinafoate) and Flovent (fluticasone propionate).

RespiClick is Teva’s breath-activated, multi-dose dry-powder inhaler (MDPI). AirDuo RespiClick is a corticosteroid and a long-acting beta2-adrenergic agonist indicated for treating asthma in patients aged 12 years and older. ArmonAir RespiClick is an inhaled corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.

AirDuo RespiClick and ArmonAir RespiClick are expected to become available in the US by prescription later in 2017. Both products have been approved in three strengths. The approved strengths of AirDuo RespiClick® are 55/14 mcg, 113/14 mcg, and 232/14 mcg administered as one inhalation twice daily. The approved strengths of ArmonAir RespiClick are 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.

Source: Teva Pharmaceutical Industries 

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