FDA News Roundup: Merck, Eisai, Novartis, And More

Novartis Secukinumab Recommended For Approval

In a unanimous vote, The Dermatologic and Ophthalmic Drugs Advisory Committee voted to support the approval of AIN457 (secukinumab) for adults suffering from moderate-to-severe plaque psoriasis that are also appropriate candidates for systemic therapy and phototherapy. Nearly 4,000 patients underwent treatment in 10 Phase 2/3 trials in psoriasis. Novartis expects the FDA to release its final decision in early 2015, preceded or followed by a decision from EU regulators. The drug, a selectiveinterleukin-17A (IL-17A) inhibitor, met all primary and secondary endpoints in clinical trials (Psoriasis Area and Severity Index (PASI) 75 and 90) and helped clear skin significantly within 12 weeks.

Taiho Gain Fast Track Designation For Cancer Drug

Colorectal cancer drug TAS-102 (nonproprietary names trifluridine and tipiracil hydrochloride) was put on the Fast-Track by the FDA last week for metastatic colorectal cancer (mCRC). Taiho Oncology is currently submitting an NDA on a rolling basis for the oral combination drug, which is currently being evaluated in the Phase 3 RECOURSE trial enrolling 800 patients whose cancer has spread or was intolerant of current treatments.

Eisai sNDA Accepted For Review

Eisai’s sNDA for AMPA receptor antagonist perampanel was accepted for review as a treatment for primary generalized tonic-clonic (PGTC) seizures. The drug, known by the brand name Fycompa CIII, is currently approved for use in epilepsy patients 12 and up as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures. Approved in the U.S. in 2012, Fycompa is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. It is currently approved in 35 countries.

FDA Approves Generic Wakefulness Tablets

Breckinridge Pharma’s generic Armodafinil tablets received a tentative approval from the FDA last week to help improve wakefulness in adults. The tablets are available in several different dosage strengths: 50 mg., 150 mg., and 250 mg. The company has submitted the Abbreviated New Drug Application (ANDA) in order to gain approval for the manufacturing and sale of the brand-name Nuvigil tablets — currently marketed by Teva’s Cephalon — prior to the drug’s patent expiration. Breckenridge has already been granted Cephalon’s approval to market the generic drugs 180 days following the launch of the different strength tablets.

TWi Pharma Lead Candidate Wins Orphan Drug Designation

TWi Pharma received an Orphan drug designation for its topical epidermolysis bullosa treatment, AC-201. The disease is characterized in certain patients by fragile skin and blisters, and the drug is indicated to prevent and reduce blisters through its inhibition of IL-1Beta signaling. The drug’s API is currently approved to treat patients with chronic rheumatic diseases in France, the EU, and in Middle Eastern countries. The company has investigated the drug in three Phase 2 trials lasting 6 months and it holds two INDs — one for the drug as a diabetes treatment and the other as a treatment for gout.

FDA Panel Backs Vertex CF Drug For Additional Mutation

An FDA Advisory Committee has voted in support of using Vertex Pharma’s cystic fibrosis drug Kalydeco (ivacaftor) as a treatment for patients 6 and up with an R117H mutation. The drug is already indicated to treat nine other mutations (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, and G1349D). According to Reuters, this specific mutation of cystic fibrosis affects 500 people in the U.S. The drug is expected to bring in upwards of $500 million this year, with a potential $160 million to come from this newest expansion. The drug costs $311,000 per patient per year.

Alkermes’ NDA Filed By FDA

Aripiprazole Lauroxil’s NDA was filed by the FDA and given an action date of August 22, 2015, Alkermes announced last week. The drug is an investigational, once-monthly injectable antipsychotic for schizophrenia that was found safe and effective at reducing Positive and Negative Syndrome Scale scores in a Phase 3 study. Aripiprazole lauroxil is also being developed in a two-month formulation.

MediciNova IPF Drug Awarded Orphan Designation

MN-001 (tipelukast) for IPF has been granted 7 years of marketing exclusivity. The company is currently assembling an IND, which it opened with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). Once a protocol is finalized and submitted to the FDA, the company hopes to launch a Phase 2 trial of MN-001 in IPF. The drug has several mechanisms of action that work as an anti-fibrotic and anti-inflammatory agent, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The drug has also shown promise as a treatment for asthma in a phase 2 trial.

Merck’s Keytruda Named Breakthrough Therapy

PD-1 therapy Keytruda was named a breakthrough therapy for Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC). Patients who have seen their disease progress during or after treatment with platinum-based chemotherapy could now potentially have an answer in Keytruda. The drug is currently indicated for unresectable or metastatic melanoma in patients whose disease has progressed following ipilimumab treatment and for those with a BRAF V600 mutation (accompanied by a BRAF inhibitor). Data from a recent Phase 1b KEYNOTE-001 study helped qualify the drug for Breakthrough Therapy Designation. In addition, the drug is currently under investigation as a monotherapy or combination therapy for 30 different cancers, with the KEYNOTE-010 and KEYNOTE-024 studies evaluating the drug’s effect in advanced lung cancer.