FDA News Roundup: Gilead, AbbVie, Boehringer Ingelheim, And More

Tybost, Vitekta Finally Gain FDA Approval

Gilead had great success with the FDA last week when the agency gave the green light to its two HIV drugs, Tybost (cobicistat) and Vitekta (elvitegravir). Tybost is a once daily therapy that has been approved for use with other anti-retroviral agents and works by increasing blood levels of protease inhibitors. Vitekta earned approval to be a combination treatment for HIV-1 with AbbVie’s Norvir (ritonavir) and other antiretroviral treatments. The journey to this approval was a long one for Gilead—both of these drugs have been in front of the FDA before, however the regulatory agency did not approve the drugs for HIV treatment on first review. This was not the case in the EU however, where the drugs have been approved for HIV treatment since the fall of 2013.

MabVax Therapeutics Gain Orphan Drug Designation

MabVax’s vaccine received an orphan drug designation for childhood cancer neuroblastoma. The bivalent vaccine aims to inhibit cancer recurrence by targeting the two most common antigens on neuroblastoma cells. This form of cancer is incredibly rare, affecting roughly 650 to 800 children in North America — a majority of which (90 percent) are under the age of five. The disease is responsible for 12 percent of all cancer deaths in children under the age of 15. The drug recently completed a Phase 1 trial at the Memorial Sloan-Kettering Cancer Center, in which it showed efficacy in treating a small group of patients who had seen their disease relapse more than once prior to MabVax treatment. The company intends to enter the vaccine into a Phase 2 trial in 2015, after finalizing the vaccine’s manufacturing and testing.

Boehringer Ingelheim Spiriva Respimat Gets FDA Thumbs Up

Spiriva Respimat (tiotropium bromide) inhalation spray for COPD-related bronchospasm was given the green light by the FDA last week. The company plans to launch the drug at the beginning of 2015. Using the Respimat inhaler, patients receive the active ingredient, tiotropium bromide inhalation powder, in a slow-moving mist. The company tested the drug in seven clinical trials involving 8,700 patients. The drug is designed to be a maintenance treatment that relaxes a patient’s airway, enabling it to stay open and preventing bronchospasm from chronic bronchitis, emphysema, or both.  This is the company’s third product that is delivered using the Respimat inhaler.

AbbVie’s Humira Gains 8^th Indication In U.S.

AbbVie earned FDA approval for Humira (adalimumab) for pediatric patients 6 and up suffering from Crohn’s disease. The treatment, which inhibits tumor necrosis factor-alpha (TNF-α), is indicated to reduce the disease’s symptoms and accomplish/maintain clinical remission in patients who have not had success with other treatment regimens. This approval marks Humira’s eighth approval in the U.S., and the drug is currently the only biologic treatment that Crohn’s patients can take at home.  Humira was investigated in the Phase 3 IMAgINE-1 trial that determined which dosages of the drug managed to cause and maintain clinical remission in pediatric patients.

pSivida’s Iluvien Approved For DME

Iluvien finally received FDA approval for patients with diabetic macular edema (DME) who have undergone corticosteroid treatment but have not seen improvements in intraocular pressure (IOP). The drug, an injected micro-insert, has proven its ability to maintain treatment of DME for 36 months after only one injection. Current treatments for this condition often require monthly anti-VEGF injection into the eye. Iluvien is expected to hit the market in early 2015. So far, the drug is also available in the U.K. and Germany and is facing pending approval in 17 other EU countries for DME—however, the indication is limited in the EU to only those who have not had success with other treatments, those with chronic DME, or those who underwent cataract surgery.

Cannabidiol Named Orphan Drug For Glioma

Insys Therapeutic’s pharmaceutical cannabidiol was granted yet another orphan drug designation for the treatment of glioma, including pontine glioma — a form of primary brainstem glioma. Eighty percent of all malignant brain tumors are gliomas.  According to the company’s CEO, the company plans to focus primarily on pontine glioma, which is often similar to glioblastoma multiforme — an indication for which the company’s cannabidiol received another orphan drug designation. The drug is also an orphan drug for Lennox-Gastaut Syndrome and Dravet Syndrome, two rare forms of epilepsy. Insys plans to keep investigating the cannabidiol’s possibility as a treatment for several other indications, including adult epilepsy, chemotherapy-induced peripheral neuropathy, and various forms of addiction.

CytRx Announced Multiple Orphan Drug Designations

Biopharm R&D company CytRx was awarded several orphan drug designations for Aldoxorubicin in the three indications, including glioblastoma multiforme (GBM), small cell lung cancer, and ovarian cancer. In the future, the company intends to launch a global Phase 2b trial for patients with relapsed small cell lung cancer and a phase 1b study that will determine the drugs effect in combination with gemcitabine before launching a trial in relapsed ovarian cancer. Aldoxorubicin is a modified version of the company’s chemotherapeutic agent, doxorubicin. The drug is currently being evaluated in a Phase 2 GBM trial and a Phase 2 Kaposi’s sarcoma trial, from both of which the company plans to announce results in the first half of 2015. Aldoxorubicin is also currently undergoing safety and efficacy testing as a second-line treatment in a Phase 3 trial for patients with soft tissue sarcoma.