FDA Just Approved Not One, Not Two But Three Drugs

(RTTNews) - Drug companies take years, even decades, and burn a tremendous amount of cash to bring a drug to the market. The journey of new drugs from lab to market is a long one. Some drugs pass the FDA muster easily, while some struggle through the arcane process of regulatory approval. According to the FDA, only 20% of drug candidates will pass all the three phases of clinical trials and eventually be approved for marketing.

December 11th saw not one, not two but three drugs getting a stamp of approval from the FDA.

Otonomy Inc.'s (OTIC) Otiprio, formerly known as AuriPro, has been approved for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

The NDA for Otiprio was accepted for review by the FDA on April 28, 2015, and was assigned a decision date of December 25, 2015. The approval comes two weeks ahead of the expected decision date.

The single-dose, physician-administered antibacterial Otiprio is the first product of Otonomy, and is expected to be launched in the first quarter of 2016.

Each year, in the U.S., approximately one million tympanostomy tube placement (TTP) surgeries are performed. Although, a number of off-label antibiotic ear drops have been used for this indication, there hasn't been an approved product till yesterday.

Otiprio becomes the first product to be approved by the FDA for the treatment of middle ear effusion during TTP surgery.

OTIC closed Friday's trading at $27.23, up 2.90%.

Privately-held Wellstat Therapeutics Corp.'s Vistogard has been approved for the emergency treatment of adults and children who receive an overdose of certain types of chemotherapy.

Administered orally, Vistogard becomes the first and only antidote for the emergency treatment of adults and children who receive an overdose of the chemotherapy agents 5-fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

The drugs 5-FU and capecitabine are essential components in treating solid tumors including those of the colon, stomach, pancreas, breast, head and neck. About 250,000 to 300,000 patients in the U.S. receive multiple treatments with 5-FU each year. It is estimated that ten to twenty percent of patients treated with 5-FU or Capecitabine develop severe or life-threatening toxicity or experience an overdose, and that approximately 0.5% of patients die, says Wellstat.

Vistogard will be marketed, sold, and distributed in the U.S. by Wellstat's commercialization partner BTG plc.

Roche's (RHHBY.OB) Alecensa has been granted accelerated approval by the FDA to treat people with advanced ALK-positive non-small cell lung cancer whose disease has worsened after, or who could not tolerate treatment with another therapy called Xalkori (crizotinib).

Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer, accounting for approximately 85-90% of all lung cancers. ALK-positive disease occurs in around 4-5% of non-small cell lung cancers and is more common in males than in females. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.

Xalkori, marketed by Pfizer Inc. (PFE) is currently the standard-of-care for advanced, treatment-naive ALK-positive NSCLC, and the median progression-free survival for patients on Xalkori is under 12 months.

In one study of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled with Xalkori, treatment with Alecensa twice daily resulted in 38 percent of participants experiencing a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.

Since Alecensa has been approved under the accelerated approval regulatory pathway, a confirmatory study is required to verify and describe the clinical benefit of Alecensa.

Alecensa has been available in Japan since September 2014, and is marketed there by Chugai Pharmaceutical Co., Ltd. there. Global sales of the drug is projected at $1 billion, according to reports.

Visit our FDA calendar to know the drugs facing regulatory decision in the coming months.